Pharmacy
Graphic Standards
Programming and Schematic Design
June 1999
lc
Table of Contents
Table of Contents
Function 3
Staff 5
Advantages of
Movable Modular Casework 6
Functional Areas 7
Order Entry/Review 7
Unit Dose Picking/Dispensing 9
IV Admixture 11
Compounding/Packaging 12
Controlled Substance Storage 13
STAT Dispensing 14
Outpatient Picking/Dispensing 15
Technician’s Workstation 16
Inventory Control 16
Bulk and Active Storage 17
Cart Holding 17
Pharmacist Office 18
Secretary/Reception 19
Break Room/Staff Lounge 20
Conference/Drug Information Center 21
Outpatient Consultation 22 Satellite Pharmacy 23 Functional Program 24 Bubble Diagram 25 Block Diagram 26 Preliminary Plan 27 Schematic Plan 28 Future Trends 29
Function
Combination System
A combination of a unit dose exchange system and conventional floor stock may be used. The floor stock is usually limited and consists of those generic medications of high usage such as aspirin, antacid, cough mixture, etc., while the majority of specific drugs are distributed by unit dose cassette exchange.
Other Methods
Medications are also administered in intravenous (IV) fluids. The addition of the medication to the sterile IV fluid is usually performed under a laminar flow hood by the pharmacist. Intravenous fluids of various types come in glass bottles, plastic bags, or syringes. Those IV fluids containing medications added by the pharmacist are then delivered to the patient units from the pharmacy.
Function
The primary function of the hospital pharmacy is the management of medications dispensed in the hospital, including the procurement, compound-ing, packagcompound-ing, and distribution of those medications for both inpatients and outpatients. In addition and of equal importance, the pharmacy staff is responsible for the recordkeeping of information regarding medications, including the patient drug profile or history, drug usage and cost data, and drug inventory and security.
The pharmacy is responsible for
providing drug information to healthcare personnel, as well as being involved in drug educational programs. Pharmacists increasingly are becoming involved in patient care as members of the medical team.
The hospital pharmacy function is monitored and regulated by national organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the American Society of Health System Pharmacists (ASHP), as well as state and local organizations, such as the State Board of Pharmacy.
Methods of Medication Distribution
The original medication order written by the physician is usually referred to as the “first dose,” “first order,” or “STAT” (immediate administration) order. This “first dose” is filled when received in the pharmacy, and sufficient dosage is supplied to cover the time until the next delivery of medications to the patient unit. The methods of continual repeat distribution of the medication by the hospital pharmacy usually fall into one of the following categories:
Conventional Floor Stock System A given amount or par level of medications are stored in medication rooms at the nurses station and restocked by the pharmacy staff at a predetermined time. Measurement and administration of the medication and appropriate
documentation are done by the nursing staff. Floor stock distribution alone is not widely used due to the lack of control, a high incidence of errors, and the waste of medications.
Unit Dose Cassette Exchange System A unit dose (single dose) of packaged medication is prepared by the pharma-cist. This unit dose is loaded into a small drawer designated for a specific patient, with all of that patient’s medications for a given time frame (usually twenty-four hours) located in the drawer. Groups of these drawers, or cassettes, are loaded into a cart and transported to the patient units. Either the cassettes or the entire cart are exchanged for the existing cassettes or cart on the unit.
Function
Flow of Medication Orders and Medications
Medication orders are always initiated by the physician in written form. The most common method of drug distribution used today is the unit dose system.
The following chart shows the typical path or flow of the written drug order and the medication to, through, and from the pharmacy.
PHYSICIAN WRITES ORDER FOR MEDICATION MEDICATION ORDER IS SENT TO PHARMACY VIA PNEUMATIC TUBE, FAX, COURIER, OR DUMBWAITER ORDER IS TIME/DATE STAMPED ORDER IS POSTED TO PATIENT PROFILE ORDER IS REVIEWED BY PHARMACIST
LABEL IS TYPED AND WORK ORDER PREPARED
WORK ORDER IS REVIEWED BY PHARMACIST
TECHNICIAN FILLS PATIENT DRAWER WITH ORDER USED CASSETTES ARE
RETURNED TO PHARMACY
PHARMACIST CHECKS PATIENT DRAWER AGAINST ORDER CASSETTES ARE REPLENISHED OR
EXCHANGED
DRAWER CASSETTES ARE PLACED ON TRANSFER CART CART IS DELIVERED TO
PATIENT UNIT
NURSE CHECKS MEDICATION ORDER AND IDENTITY OF PATIENT
NURSE ADMINISTERS MEDICATION TO PATIENT
Staff
Technicians
Pharmacy Technicians
Technicians may have various levels of education. It is their responsibility to perform tasks, such as packaging, picking, labeling, or inventory, as directed by the pharmacist.
Staff
PharmacistsDirector of Pharmacy
The director of the pharmacy is a registered pharmacist often holding an advanced education degree. The responsibility of this position is the total management of the direction and operation within the pharmacy including administrative, technical, functional, and policy issues.
In addition, the director establishes relationships and interfaces with other hospital staff and committees as well as pharmaceutical representatives. It is the responsibility of the director to meet or exceed the standards of compliance of regulatory and accreditation organiza-tions.
Pharmacist
The pharmacist is licensed or registered to provide pharmaceutical services. The responsibility of the position is the management of the daily function of the department, primarily the accuracy of drug distribution.
The pharmacist’s accountability also includes the management and review of work done by technicians, interns, or residents and interfacing with patients, nursing, and medical staff.
Support Staff
Clerical Staff
Clerical positions within the pharmacy may include receptionist, word processing, inventory, and/or procure-ment responsibilities.
Advantages of Movable Modular Casework
Movable Modular Casework
In the past, hospital pharmacies were planned using fixed casework or millwork. However, fixed construction does not respond to the rapidly changing technology seen in healthcare facilities today.
This fixed casework is often
inaccurately described as “modular.” While these cabinets may be offered in many different widths for “flexibility,” they are attached to a custom-sized countertop to form an immovable, inflexible mass. By comparison with movable modular casework, fixed casework is difficult to install, reconfigure, and reuse.
Movable modular casework offers the following major advantages and differences when compared with fixed casework or millwork:
·
Movable modular caseworkcomponents require less square footage within a pharmacy department.
·
Movable modular casework components have been specifically designed to meet the functional requirements of the pharmacy department.·
Energy capabilities within the movable modular casework system allow the immediate addition or reconfiguration of all new and existing electrical equipment.·
Movable modular casework components have been designed to function as a movable system allowing the pharmacy to integrate with the patient units they serve, using the same components, for example, medication carts and satellite pharmacies using the same components.·
All movable modular caseworkcomponents can be easily rearranged or reused by the end user, either minor or major reconfigurations, allowing ongoing changes with new technology.
·
Additional components can be added at any time.Financial Advantages
The initial cost of movable modular casework is competitive with fixed casework or millwork. However, the life cycle cost of movable modular casework is far less than fixed casework because of
·
Longer product life.·
Minimal maintenance cost.·
Continual reuse of the components for new or different functions.·
Ability to install and reconfigure with little downtime.·
Accelerated depreciation rate, especially important to “for-profit” organizations.For preliminary budget purposes, movable modular casework for a pharmacy has an average price in the range of $177 to $265 per linear foot. This range will be affected by the density of overhead and undercounter storage components and the type of support structure used (wall-mounted versus panels).
Advantages of Movable Modular Casework
Hospital pharmacies may differ somewhat in square footage, method of operation, and staffing based on the size of the hospital, type of hospital, and scope of outpatient services, but each hospital pharmacy has certain functional areas in common. The following pages describe the advantages of movable modular casework, give a brief description of the functional areas of hospital pharmacies, and provide typical plan views of movable modular casework applications.
Order Entry/Review
Functional Areas
Order Entry/ReviewThis area of the pharmacy is the
“communications hub” of the department and is often in a central or front location. A written medication order is received in order entry and reviewed by the
pharmacist. Orders are compared with the patient’s medication history or “profile” to prevent the administration of antagonistic or duplicated drugs. From this location, the order is assigned to a pharmacist or technician for selection and then rechecked by the pharmacist. All original written orders may be stored in this area.
Work space must be provided for several people, as well as sufficient file and equipment space (telephone, fax machine, computers, copy machine, and printers).
The entire order entry/review station can be planned using a freestanding panel or frame system with movable modular components to provide the following:
·
Maximum utilization of space.·
Continual integration of computer technology.·
Electrical capabilities for continual integration of phones, fax, copiers, printers, etc.Movable modular components may include
·
Corner work surfaces with keyboard trays or drawers to accommodate computers and printers.·
Cantilevered work surfaces.·
Overhead storage for manuals and technical reference materials.·
Above work surface counter or transactional work surface.·
Lateral and pedestal files.·
Task lighting under transactional counter.Plan Views of Order Entry/Review Stations
An order entry/review station will range in size from 50 to 150 square feet based on the size of the hospital and the amount of electronic equipment and staff
requirements. Plan A
18 linear feet work surface 40 filing inches
100 square feet
Plan B
10 linear feet work surface 20 filing inches 50 square feet
Order Entry/Review
Plan A Plan B 7' - 2"ORDER
ENTRY/REVIEW
7' 9'ORDER
ENTRY/REVIEW
11' - 2"Unit Dose Picking/Dispensing
Medication containers (subcontainers) can be arranged in a gravity-feed position or on flat shelves.
Work surfaces for clerical and computer needs can be incorporated into the station at any time.
Movable Modular Casework Applications The components for unit dose picking stations can be planned in many different configurations based on the space parameters, number of drugs to be dispensed, additional functions and equipment within the station, and the number of technicians using the station. The use of a freestanding panel system for the configuration of the stations provides the most efficient use of space as well as the capability of storing the maximum number of medications.
Unit Dose Picking/Dispensing
Hospital-dispensed medications are packaged in single doses for accuracy and efficiency of dosage administration. These single dose packages are referred to as “unit dose” and are usually the most frequently ordered or high-volume-use medications.
The need for the retrieval of the most frequently used medications in an efficient, time-saving manner has led to the development of the unit dose “picking station.”
The creation of a U-shaped workstation provides a space of limited dimensions containing a maximum quantity of drugs and allows the pharmacist to “pick” the appropriate drug. The pharmacist can fill drug orders with little wasted time and motion having high-volume or fast-moving drugs within arm’s length. Multiple stations can be planned based on the number of drugs used and the number of hospital beds. A standard may be one picking station per 100 beds. The organization of these medications will vary among hospitals.
Unit Dose Picking/Dispensing
Plan A Plan Views of Unit Dose Picking Stations
Unit dose picking stations will vary in size and configuration. The number of stations and square footage depends on the size of the hospital and the number of drugs in the formulary.
Drug Work Square
Plan Bins Surface Feet
A 255 avg 6 LF 55 B 190 avg 6 LF 42 C 450 avg 8 LF 72 D 480 avg 10 LF 90 Plan B Plan C 8' - 6 1/2" Plan D 8' - 6 1/2"
UNIT DOSE
PICKING
10' - 6 1/2" 8' - 6 1/2"UNIT DOSE
PICKING
6' - 6 1/2"UNIT DOSE
PICKING
6' - 6 1/2" 8' - 6 1/2" 6' - 6 1/2"UNIT DOSE
PICKING
IV Admixture
Movable Modular Casework Applications
Movable modular casework components are used for work areas and storage of fluids and medications and may include
Plan View of an IV Admixture Room An IV admixture room will range in size from 160 to 500 square feet.
46 linear feet work surface 92 linear feet overhead storage
2 lockers for IV storage 1 L cart
407 square feet
IV Admixture
A specific area of the pharmacy is designated for the function of adding medications to intravenous (IV) fluids prior to administration to the patient. Although code requirements may differ, this area must be the cleanest part of the department. It is recommended that IV admixture be in a closed room with positive pressure for isolation and cleanliness in preventing contamination. The injection of the medication into the IV fluid is carried out under a laminar flow hood. The IV admixture room should provide space for a limited supply of intravenous fluids and medications, as well as sinks, refrigerators, computers, and work areas.
The size of an IV admixture room will vary based on the size of the hospital, types of medications being added to fluids, and the number of hoods needed.
·
Cantilevered work surfaces for clerical and technical work areas.·
Mobile process tables and smaller mobile L carts for movable work areas adjacent to the flow hood.·
Lockers to store intravenous fluids and additives.·
Lockers on wheels (TR3 cart) moved to the storage area for restocking of fluids. 22' 18' - 6"IV ADMIXTURE
CHEMO HOOD HOOD HOOD REFCompounding/Packaging
Compounding/Packaging
The compounding area of the pharmacy is the section where liquid and topical medications are mixed and stored. There is a need for a sink, medication storage, computer, label printer, and sufficient work surface.
In the packaging area, medications in both liquid and tablet form that are not manufactured as a single-dose unit can be divided and packaged as needed. In many smaller hospitals, compounding and packaging may be combined in the same location.
Movable Modular Casework and Furniture Systems Applications
A combination of both wall-mounted and freestanding modular components are appropriate for this area. The area is usually configured along an existing wall to access plumbing.
All of the work surfaces, sink units, and overhead supply storage can be programmed with movable modular components.
Additional storage and work space can be planned using freestanding panels. Large mobile tables for labeling and packaging equipment provide flexibility for the packaging function.
Packaging
8 linear feet work surface 16 linear feet overhead storage 40 square feet
Plan Views of Compounding/Packaging Areas
Compounding and packaging areas combined will range in size from 75 to 150 square feet.
Compounding
10 linear feet work surface 16 linear feet overhead storage 50 square feet 10' - 1" 2'
COMPOUNDING
2' 8' - 1"PACKAGING
Controlled Substance Storage
Controlled Substance Storage
Narcotics and other government-controlled drugs are stored in a vault or locked room in the pharmacy, usually located away from the primary entrance but in a highly visible location.
Movable Modular Casework Applications Modular shelving is applicable for the controlled substance storage room within the pharmacy. Double-locking modular medication carts are used for transporting controlled substances to the patient units.
Plan View of a Controlled Substance Storage Room
A controlled substance storage room will range in size from 45 to 120 square feet.
4 linear feet work surface 52 linear feet storage 80 square feet 7' - 8" 10' - 8"
CONTROLLED
SUBSTANCE
STORAGE
STAT Dispensing
Movable Modular Casework Applications Similar to the unit dose picking station, this STAT picking area should be configured using freestanding panels, hanging drug containers, and cantile-vered work surfaces.
Plan View of a STAT Dispensing Station A STAT dispensing station will range in size from 60 to 120 square feet.
12 linear feet work surface 24 linear feet overhead storage 165 drug bins average
80 square feet
STAT Dispensing
When a “STAT” or immediate drug order is issued by a physician, that order needs to be filled and delivered to the patient unit as soon as possible, rather than waiting for the next routine floor delivery. An area of the pharmacy is often set aside for STAT dispensing and contains smaller quantities of frequently ordered drugs. Hence, these STAT orders can be filled without disrupting the flow of normal order picking and filling.
10' - 1 1/2"
STAT
DISPENSING
8' - 4"Outpatient Picking/Dispensing
Movable Modular Casework Applications The same movable modular casework components used in the primary
pharmacy are applicable in the outpatient area and may include
·
Cantilevered work surfaces.·
Regular and extra-deep modular shelving units.·
Drug bins.·
Cantilevered sink unit.Plan View of an Outpatient Dispensing Station
An outpatient dispensing station will range in size from 50 to 100 square feet.
10 linear feet work surface 12 linear feet overhead storage 64 square feet
Outpatient Picking/Dispensing
The hospital pharmacy also may dispense medications to outpatients. To avoid direct competition with the retail pharmacy, the hospital pharmacy must purchase, discount, and maintain separate stock for outpatients.
The outpatient dispensing area requires sufficient medication storage space, work surface, and space for equipment
(computer, printer, label printer, refrigerator).
The size of this space depends on the size of the hospital and the number of outpatient orders received.
Plan View of an Outpatient Picking Station An outpatient picking station will range in size from 60 to 100 square feet.
8 linear feet work surface 42 linear feet storage 165 drug bins average
70 square feet
In some smaller hospitals, this may be an isolated alcove, while in others, such as military, teaching, and veterans hospitals, this may be a major department. Picking and dispensing areas may be separated in larger hospitals.
If the outpatient dispensing function of the pharmacy warrants, an area should be provided for patients to wait while their medication orders are filled. This can be provided as a seating area in an alcove or small room at the primary entrance to the pharmacy. This area should be visible from the reception or order entry station and should be secure from the primary area of the pharmacy.
8' - 4" 8' - 7"
OUTPATIENT
PICKING
8' - 0 1/2"OUTPATIENT
DISPENSING
8' - 1 1/2"Technician’s Workstation, Inventory Control
Technician’s Workstation
Technicians in the pharmacy need small workstations or office areas for
completing paperwork, accessing computer programs, telephone conferencing, and reading medical manuals and reports.
Movable Modular Casework and Furniture Systems Applications Components for these stations, either wall-mounted or panel-hung, offer the most flexibility for use of the space. Freestanding panels offer varying degrees of privacy and can be configured based on individual needs.
Plan View of a Technician’s Workstation A technician’s workstation will range in size from 45 to 90 square feet.
10 linear feet work surface 16 linear feet overhead storage 20 filing inches
55 square feet
Plan View of an Inventory Control Station 10 linear feet work surface
20 linear feet overhead storage 40 filing inches
40 square feet
Movable Modular Casework and Furniture Systems Applications Wall-mounted or panel-hung modular components can be used in this area providing work surface, storage, and filing capabilities.
Inventory Control
A small workstation adjacent to bulk and active storage provides a space for maintaining information regarding the inventory of the pharmacy. From this area, the staff will log in drugs at arrival in the department, monitor supplies within the pharmacy, and procure medications as needed. 4' - 1 1/4" INVENTORY CONTROL STATION 8' - 1 1/2" 6' - 6 1/2" 8' - 6 1/2"
TECH
WORKSTATION
Storage, Cart Holding
Bulk and Active Storage
Bulk storage is the area of the pharmacy where medications and intravenous fluids are stored in bulk quantities. These bulk supplies are generally removed from the shipping boxes, prior to delivery to the pharmacy, or stored in an anteroom outside of the pharmacy because of the associated dust and dirt from the outer packaging. Bulk storage space can be conserved by using a movable aisle system.
The active storage area contains ready-to-use supplies in smaller quantities than bulk storage and is accessed to restock unit dose picking stations, compounding, and packaging and house the slower-moving medications not included in the picking station.
Movable Modular Casework Applications Freestanding modular shelving and mobile carts are appropriate for the bulk and active storage areas.
Shelving units can be configured with shelves of 24", 30", or 48" widths and can be arranged in many different combinations.
Plan View of Shelving for Bulk and Active Storage
40 linear feet per 4-foot section, shelving both sides
25 square feet per 4-foot section
Movable Modular Casework Applications A modular medication cassette transfer cart will allow integration with the movable modular casework.
BULK/ACTIVE STORAGE
10' - 6 1/2"
2' - 4 1/2"
Cart Holding
The cart holding area of the pharmacy should allow sufficient space for storing medication and/or transfer carts for the patient units awaiting delivery or exchange. The amount of space will depend on the method of cart replenish-ment or exchange.
CASSETTE TRANSFER CART
4' - 11 3/4"
Pharmacist Office
Pharmacist Office
The director of the pharmacy, as well as other pharmacists, may have private offices within the department. Small conferences and meetings with drug representatives and other hospital staff may require privacy and confidentiality. Consistency between systems used in administrative and clinical areas allows for compatibility and flexibility when dealing with future changes.
Movable Modular Casework and Furniture Systems Applications Either full-height fixed, demountable walls or freestanding modular panels are appropriate.
Plan View of a Pharmacy Director’s Office
14 linear feet work surface 24 linear feet overhead storage 40 filing inches
150 square feet
Plan View of an Assistant Pharmacy Director’s Office
8 linear feet work surface 20 linear feet overhead storage 136 filing inches 100 square feet
PHARMACY
DIRECTOR
10' - 9 1/2" 13' - 6" 9' - 7 1/2" 10' - 9 1/2"ASSISTANT
DIRECTOR
Secretary/Reception
Secretary/Reception
Most hospital pharmacies will have administrative areas for secretaries and clerks. These should be located toward the front of the pharmacy to discourage traffic into the clinical areas where medications are accessible. NOTE: Pharmacies are required to display all their various licenses.
Plan View of a Secretary/Reception Area A secretary/reception area will range in size from 75 to 150 square feet.
12 linear feet work surface 16 linear feet overhead storage 40 filing inches
75 square feet
Movable Modular Casework and Furniture Systems Applications
Modular furniture system components can be used to furnish these areas and may include
8' - 9 1/4"
8' - 7 3/4"
SECRETARY/
RECEPTION
·
Tool bars and accessories for paper handling.·
Corner work surfaces with keyboard tray or drawer to accommodate computers and printers.·
Flipper storage, display shelves, and open shelves for storing manuals and books.·
Tackboards or display shelves to display documents.·
Task lights and personal lights.·
Freestanding tables or peninsula work surfaces for conferencing.·
File storage in pedestal drawers, hanging drawers, and hanging or freestanding lateral files.Break Room/Staff Lounge
Break Room/Staff Lounge
Pharmacy departments generally provide a staff lounge for coffee breaks and meals. It is important to locate this break room close to or within the pharmacy department especially for staff working the second and third shifts. Since the number of staff working these shifts is small, it is preferred that they do not leave the area for breaks and be on hand for STAT orders or emergencies. Space should be provided for a refrigerator, microwave oven, coffee maker, and supplies.
Movable Modular Casework and Furniture Systems Applications The break room/lounge area can be planned using modular components and may include
·
Wall strips with cantilevered work surface and overhead storage or heavy-duty storage work surface with C frame storage units and drawers.·
Tables and seating.·
Tackboards to display information.Plan View of a Break Room/Staff Lounge A break room/staff lounge will range in size from 100 to 200 square feet.
8 linear feet work surface 12 linear feet overhead storage
125 square feet 10' - 9 1/2"
11' - 7"
Movable Modular Casework and Furniture Systems Applications
Movable modular casework components and modular furniture systems allow for future flexibility and change. The requirements of this area will be unique to each pharmacy but may include
Conference/Drug Information Center
It is the responsibility of the pharmacy to provide current drug information and education for the medical staff, including the pharmacists, physicians, and nurses. A space is usually provided in larger hospital pharmacies that is accessible for this purpose. A large amount of shelving is provided to house current periodicals and other reference manuals. A conference type of table and seating are available for reading or studying, as well as a small copy machine and space for a computer.
·
Comfortable seating.·
Task lights to illuminate work surfaces for reading.·
Limited filing for articles and reports.Plan View of a Conference/Drug Information Center
40 linear feet storage 48 filing inches 150 square feet
·
Extra-deep modular shelving units to hold large reference manuals.·
Tables or work surfaces for sitting and reading.Conference/Drug Information Center
CONFERENCE/ DRUG INFORMATION
CENTER
15' - 6 1/2" 9' - 9"
Outpatient Consultation
Movable Modular Casework and Furniture Systems Applications
Movable modular casework components and modular furniture systems allow for future flexibility and change. The requirements for this area may include
·
Conference tables and seating.·
Wall strips with shelves, marker boards, and tackboards.Outpatient Consultation
The pharmacist will often meet with patients and their families to discuss a medication program, instruction in administration, expected drug results, and possible drug complications. In larger hospitals, there is often a consultation room within the pharmacy which allows for the privacy of these meetings.
Plan View of an Outpatient Consultation Room
32 linear feet storage 120 square feet
9' - 9"
12' - 5" OUTPATIENT
Satellite Pharmacy
Satellite Pharmacy
Small satellite pharmacies may exist in any patient unit or service department but are more commonly placed in the more acute care units, such as critical care units, emergency departments, surgery, and chemotherapy units.
This decentralization of the pharmacy function allows for more rapid response to the needs of the patient and allows the pharmacist more involvement in the clinical therapy of the patient.
Movable Modular Casework Applications The same movable modular casework components used in the main pharmacy are appropriate for the satellite
pharmacy, allowing for continual flexibility and change in the space.
Plan View of a Satellite Pharmacy A satellite pharmacy will range in size from 120 to 250 square feet.
18 linear feet work surface 28 linear feet overhead storage 80 drug bins average
1 locker
1 medication cart 140 square feet
The space will vary in size but will usually contain a small drug picking area, sink, refrigerator, computer, printer, label printer, and controlled substance storage. Some satellite pharmacy areas may have a small laminar flow hood.
The satellite pharmacy is staffed, stocked, and serviced by the primary pharmacy department.
Modular carts are appropriate for the transfer of medications to the satellite pharmacy. 12' - 3" HOOD
SATELLITE
PHARMACY
11' - 3"Functional Program
Number Department Area Square Feet
Movable Modular Casework
Unit Dose Picking/Dispensing Stations @ _______ sq. ft. IV Admixture Room
Compounding Area Packaging Area
Controlled Substance Storage Room STAT Dispensing Station
Outpatient Picking Stations @ _______ sq. ft. Outpatient Dispensing Stations @ _______ sq. ft. Bulk Storage Area
Active Storage Area Cart Holding Area
Staff Toilets @ _______ sq. ft. Janitor’s Closet
Subtotal
Modular Furniture Systems
Order Entry/Review Station
Technician’s Workstations @ _______ sq. ft. Inventory Control Station
Pharmacist’s Offices @ _______ sq. ft. Secretary/Reception
Staff Lounge Conference Room Drug Information Center Outpatient Consultation Room
Subtotal TOTAL NET SQUARE FEET
Net-to-Gross Conversion Factor X TOTAL GROSS SQUARE FEET
Bubble Diagram
Bubble Diagram
The bubble diagram of the pharmacy department demonstrates typical departmental relationships and interaction between areas. Necessary adjacencies within the department become clear. OUTPATIENT DISPENSING IV ADMIXTURE PICKING ORDER ENTRY CART HOLDING ACTIVE STORAGE PACKAGING BULK STORAGE RECEIVING COMPOUNDING OUTPATIENT CONSULTING SECRETARY/ RECEPT OFFICES NARCOTICS
Block Diagram
Block Diagram
The block diagram demonstrates the adjacencies and relative sizes for the areas within a typical pharmacy. Evaluation of the work flow and materials flow from the bubble diagram has determined this initial general layout.
The size of each area is determined by combining the typical movable modular casework plans for each identified function. Traffic patterns are developed, and an overview of the general work process can be evaluated.
Preliminary Plan
Preliminary Plan
The preliminary plan clarifies the pharmacy space requirements by showing the location of all the fixed walls and open areas and identifies entrances, exits, and exact traffic patterns.
Schematic Plan
Schematic Plan
The schematic plan shows all of the specific movable modular casework, modular furniture systems, and materials handling components appropriate for a typical pharmacy. ASS'T DIR DIRECTOR STAFF LOCKER ROOM WAIT STAT DISPENSING ORDER ENTRY/ REVIEW NIGHT TECH WORK AREA TOPICALS
UNIT DOSE PICKING CONSULTATION CONFERENCE DRUG INFO OUTPATIENT WAITING SECRETARY RECEPTION OUTPATIENT PICKING OUTPATIENT DISPENSING TECH WORK AREA TECH
WORK AREA LIQUIDS 70' - 10" 65' - 3" CART STORAGE IV ADMIXTURE CART STORAGE ACTIVE STORAGE IV STORAGE RECEIVING/BREAKDOWN PACKAGING CONTROLLED SUBSTANCE STORAGE COMPOUNDING BULK STORAGE BREAK ROOM/ LOUNGE INVENTORY CONTROL
Future Trends
Future Trends
AdministrationNew pharmacy practices will continue to grow, with patient counseling and patient monitoring showing the most growth. “Pharmaceutical care” will concentrate on the prevention of drug-related problems.
Medication Dispensing
Most unit dose packs will be bar coded with operational and cost savings, and nurses will carry bar code wands to tabulate drug administration.
The unit dose concept will continue to grow.
There will be an increase in the number of “STAT” or first doses coming from the pharmacy or satellite pharmacy because very ill patients require more medication changes.
New dosage forms, such as osmotic pumps, controlled release systems, and transdermal delivery, are appearing. IV admixture use is increasing with more complicated, expensive, and perishable drugs such as biotech drugs,
hyperalimentation, and the mix of several drugs in one IV.
First doses, PRN doses, and narcotics will be kept in cabinets in nurses stations, often dispensed by automated equipment. The pharmacists will more often be stationed in the satellite pharmacy on the patient unit with more patient contact, consulting, and evaluation of drug therapy.
Automated drug dispensing machines will become more prevalent within the pharmacy.
Layout
The relative proportions of office, reference, storage, and drug distribution spaces will be constantly shifting and changing.
Traffic congestion and traffic patterns are becoming more complex with patient consultations within the pharmacy growing at a rapid rate.
Bulk storage will decrease as computers, prime vendors, and formulary practices increase.
The size of IV admixture rooms will increase because of the increased volume of medications administered by this method.
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Pharmacy
Clean Room
Technical Bulletin
June 1999
Pharmacy
Clean Room
Table of Contents
Glossary 3 Traditional Preparation of Sterile Products and Associated Problems 5 Description of Clean Room
and Activities 5 What is a Clean Room? 5 Clean Room Activities 5 Clean Room Standards and Guidelines 6 Federal Standard 209E 6 Technical Assistance Bulletin (TAB) Guidelines 6 Risk Levels Established
by the Technical Bulletin 6 Enforcement of Guidelines 7 Anteroom Description
and Activities 7 Material Transfer Between
Anteroom and Clean Room 8 Considerations For Planning
And Design 8 Clean Room Construction Methods 8 Allocated Space 8 Clean Room Size 8 Supply Management 9 Operational Management 9 Allocation of Responsibilities 9 Design Requirements 9 Typical Installations 10 Plan View 1 11 Plan View 2 13 Plan View 3 15 List of Appropriate
Herman Miller Product 16 Anteroom 16 Clean Room 16 Herman Miller Contact Information 16 Allied Suppliers of
The Clean Room Package 16 V-Wall Modular Wall Systems 16 Gencorp 16 CRI (Clean Rooms International) 17 List of V-Wall Representatives 18
Pharmacy
Clean Room
Glossary
Anteroom
A support area adjacent to the clean room. Anteroom handles distribution and particle-producing activities which should be separated from the clean room. Aseptic Preparation
The technique involving procedures designed to preclude contamination (of drugs, packaging, equipment, or supplies) by microorganisms during processing.
ASHP
American Society of Health System Pharmacists, Inc.
Batch Preparation
Compounding of multiple sterile-product units, in a single discrete process, by the same individual(s), carried out during one limited time period.
Biological Safety Cabinet
Also known as a bio-safety hood. Used for preparation of toxic, infectious, or sterile substances. This will always be a vertical flow hood.
Clean Room
A room in which the concentration of airborne particles is controlled and there are one or more clean zones. (A clean zone is defined as space in which the concentration of airborne particles is controlled to meet a specified airborne-particulate cleanliness class.) Clean rooms are classified based on the maximum number of allowable particles 0.5 micron and larger per cubic foot of air. For example, the air particle count in a Class 10,000 clean room may not exceed a total of 10,000 particles of 0.5 micron and larger per cubic foot of air.
Clean Room Manufacturer
A company which provides a variety of products and services for clean room environments.
Closed-System Transfer
The movement of sterile products from one container to another in which the container-closure system and transfer devices remain intact throughout the entire transfer process. The closure is compromised only by the penetration of a sterile, pyrogen-free needle, cannula, or equivalent needle-free system through a designated stopper or port to effect transfer, withdrawal, or delivery. Withdrawal of a sterile solution from an ampule in a Class 100 airflow hood would generally be considered acceptable; however, the use of a rubber-stoppered vial, when available, would be preferable.
Compounding
The mixing of substances to prepare a medication for patient use. This activity would include dilution, admixture, repackaging, reconstitution, and other manipulations of sterile products. Controlled Area
The area designated for preparing sterile products.
CRI (Clean Rooms International) A co-operative supplier of clean room air pumps, filters, and lighting equipment. Critical Area
Any area in the controlled area where products or containers are exposed to the environment.
Critical Site
An opening providing a direct pathway between a sterile product and the environment or any surface coming in contact with the product or environment.
Critical Surface
Any surface that comes into contact with previously sterilized products or containers.
Expiration Date
The date (and time, when applicable) beyond which a product should not be used (i.e., the product should be dis-carded beyond this date and time). NOTE: Circumstances may occur in which the expiration date and time arrive while an infusion is in progress. When this occurs, judgment should be applied in determining whether it is appropriate to discontinue that infusion and replace the product. Organizational policies on this should be clear.
HEPA Filter
A high-efficiency particulate air (HEPA) filter composed of pleats of filter medium separated by rigid sheets of corrugated paper or aluminum foil that direct the flow of air forced through the filter in a uniform parallel flow. HEPA filters remove 99.97% of all air particles 0.3 micron or larger. When HEPA filters are used as a component of a horizontal-or vertical-laminar-airflow hood, an environment can be created consistent with standards for a Class 100 clean room.
Horizontal Flow Hood
Airflow hood used for preparation of nontoxic sterile products which pose no danger to the technician. Also known as a Laminar Flow Hood.
Laminar Air Flow Hood
Generic term for a vertical, horizontal or bio-safety hood. These terms may be used interchangeably.
Micron
A unit of measure equal to one-millionth of a meter (.000001 meter).
Pharmacy
Clean Room
Quality Assurance
Activities used to ensure that the processes followed in the preparation of sterile drug products lead to products that meet predetermined standards of quality.
Quality Control
Testing activities used to determine that the ingredients, components (e.g. containers), and final sterile products prepared meet predetermined require-ments with respect to identify purity, non-pyrogenicity, and sterility. Repackaging
The subdivision or transfer from a container or device to a different container or device, such as a syringe or ophthalmic container.
Sterilizing Filter
A filter (of 0.2 micron or less) that will produce a sterile effluent when chal-lenged with a solution containing the microorganism Pseudomonas diminuta, at a minimum concentration of 10 organisms per square centimeter of filter surface.
Temperatures (USP)
Frozen means temperatures between -20 and -10°C (-4 and 14°F). Refrigerated means temperatures between 2 and 8°C (36 and 46 °F). Room temperature means temperatures between 15 and 30°C (59 and 86°F).
USP
Procedures and products that adhere to United States Pharmacopeial standards. USPC
United States Pharmacopeial Conven-tion, Inc. Generally referred to as USP. An agency which sets pharmaceutical standards. Authors of a pharmacy advisory document entitled “Dispensing Practices for Sterile Products Intended for Home Use.”
V-Wall
A modular wall system affiliated with Herman Miller, Inc. that can be used to create a certified Clean Room. V-Wall modular walls integrate with Herman Miller CO and AO components. Validation
Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Vertical Flow Hood
Airflow hood used for preparation of toxic sterile substances such as chemo-therapeutic agents. The HEPA filtered air emerges from the top and passes downward through the work area to protect the technician when preparing toxic substances.
Pharmacy
Clean Room
Traditional Preparation of
Sterile Products
and Associated Problems
For many years, standard practice in many pharmacies has been to prepare sterile products within the microenviron-ment of an unidirectional airflow hood. Often the airflow hood was set up in an area adjacent to the main pharmacy. The airflow hood kept the immediate preparation area clean but surfaces surrounding the hood were subjected to airborne particles and contaminants. These contaminants could potentially compromise the quality and aseptic integrity of sterile products.
Because documented cases of sterile-product contamination have occurred, the pharmacy profession has now established recommendations to promote higher quality standards for prepared sterile products.
Since 1993 there has been a significant upgrading of performance requirements for institutional pharmacies. This upgrading has been prompted by the “Technical Assistance Bulletin (TAB) on Quality Assurance for Pharmacy-Prepared Sterile Products” published in November 1993 by the American Society of Health System Pharmacists, Inc. (ASHP).
Some pharmacists regard the TAB as a guideline only and choose not to follow all the recommendations. However, the TAB now makes clean room technology desirable for most pharmacies. The bulletin has also created more awareness among pharmacists concerning clean room procedures.
The USPC has also distributed an advisory document entitled “Dispensing Practices for Sterile Products Intended for Home Use.” While this document is intended for home care, the USP intends to expand its scope and context to include the preparation of sterile prod-ucts in pharmacies.
Description of Clean Room and
Activities
What is a Clean Room?
In essence, the ASHP’s Technical Assistance Bulletin has formalized recommendations for creating a clean environment to surround the airflow hood microenvironment.
Clean room technology has been used for many years in microelectronics assembly, biotech research, and pharma-ceutical manufacturing. Recently clean rooms have been adapted for pharmacy. A clean room is a confined area in which the air must be so pure that even micron-sized particles are screened out. For example, the particle count in a Class 10,000 clean room may not exceed a total of 10,000 particles of 0.5 micron or larger per cubic foot of air. For size comparison, a micron is equal to one-millionth of a meter.
The key issue in the clean room is to provide an area for IV preparation that is free of contamination and limited in the number of airborne particles.
The reason for filtering these particles is to prevent microbes from migrating independently. Microbes are typically carried by airborne dust and organic particles. The clean room can effectively remove viable microbes by removing particles (less than or equal to 0.5 micron) from standing surfaces and incoming air.
This air purity is achieved through the creation of a shell or secluded area that is sealed off from the rest of the environ-ment.
To compare this level of purity, condi-tioned air in an average office space is exchanged six times an hour. For example, in a common clean room, air is filtered and fully exchanged 60 or more times an hour.
Because of this airflow rate and the number of filters and air pumps required to sustain it, a clean room can be a high-noise and high-heat environment.
Clean Room Activities
IVs, piggybacks, and syringes of medication are prepared in the clean room area of the pharmacy. The clean room may also be known as the clean area or critical area. The process of preparing IVs may also be known as sterile preparation of parenteral products or IV admixture.
Many IVs arrive from the manufacturer already containing a solution and will not require additional preparation. Other types of IVs require a separate medica-tion to be added to the solumedica-tion in a process called IV admixture. This admixture process occurs under a horizontal or vertical airflow hood that is found inside a clean room or clean area in the pharmacy.
Under a laminar airflow hood there is a constant pressure of twice-filtered clean air that flows in a laminar pattern across the work surface at approximately 90 linear feet per minute. This clean air physically sweeps the work area and prevents the intrusion of contaminated room air. The term “laminar” indicates that the final filter channels air into parallel streams to promote uniform air flow.
There are two types of hoods used in admixture areas. In both types the air is drawn through a High-Efficiency Particulate Air (“HEPA”) filter which removes 99.9% of particles that are 0.3 micron or larger, thereby virtually eliminating airborne particles.
In a vertical flow hood, HEPA-filtered air emerges from the top and passes downward through the work area. This directs vapors and splashes away from the technician. These hoods are used to protect the technician when preparing toxic substances such as chemotherapeu-tic agents.
Pharmacy
Clean Room
1
Technical Bulletin 6A horizontal flow hood moves air toward the worker. Horizontal flow hoods are used for preparation of nontoxic parenterals (antibiotics, enteral and parenteral nutrition) that are not a threat to the technician. The horizontal movement allows a more uniform, laminar flow of air.
Clean Room Standards and
Guidelines
Federal Standard 209E
The Federal Standards Bureau deter-mines how clean a clean room must be. It has set up a classification system called (at time of publication) Federal Standard 209E. The standard states that to achieve the goals of clean room operation, potentially damaging particles should be regulated.
Clean rooms are classified according to the number and size of particles found in a given cubic foot of space once the room is operational. The number of particles determines the class of the room. For example, a Class 100,000 condition allows no more than 100,000 particles 0.5 microns and larger per cubic foot of air. A Class 10,000 room allows no more than 10,000 sub-micron particles per cubic foot and a Class 100 room allows no more than 100 sub-micron particles per cubic foot.
Technical Assistance Bulletin (TAB) Guidelines
Pharmacists are responsible for the aseptic preparation of sterile products. The “Technical Assistance Bulletin (TAB) on Quality Assurance for Phar-macy-Prepared Sterile Products,” published by the ASHP in November 1993, describes appropriate practice procedures for preparation of sterile products matched with potential risks posed to the patients. The recommenda-tions apply to pharmacy services in hospitals, community pharmacies, nursing homes, home health care organizations, and other settings. The Technical Bulletin is organized by several categories:
• Policies and Procedures • Personal Education • Training and Evaluation • Storage and Handling • Facilities and Equipment • Aseptic Preparation Techniques • Process Validation
• Expiration Dating • Labeling
• Product Evaluation and Documentation
Although you should gain general knowledge regarding the Technical Bulletin, the section most applicable to Herman Miller is “Facilities And Equipment.”
You will also need to become familiar with the risk level of products as discussed in the Technical Bulletin.
Class 100,000 Class 100
Risk Levels Established by the Technical Bulletin
The Technical Bulletin groups sterile products into three levels of risk to the patient, increasing from least potential risk (Level 1) to greatest potential risk (Level 3). Each risk level has different quality assurance recommendations for product integrity, patient safety, and facility design. Level 1 preparation is the least demanding. Level 2 includes products prepared for longer-term usage and carries higher risk to the patient if the product is contaminated; therefore, more stringent requirements are appro-priate. The quality assurance activities for risk Level 3 are even more demand-ing in terms of process and facility requirements.
Risk Level 1—
Requires sterile products to be prepared inside a horizontal or vertical laminar airflow hood (Class 100 environment). The guidelines recommend that the hood be placed in a limited access area sufficiently separated from other pharmacy operations to minimize the potential for contamination from outside sources, with drugs and supplies stored on shelving above the floor.
Risk Level 2—
Calls for a Class 100,000 clean room with positive air pressure relative to adjacent pharmacy areas. Other areas (such as the anteroom) should be separated from the controlled area by an air barrier.
Risk Level 3—
Sterile products should be prepared: • In a Class 100 horizontal or vertical
laminar airflow hood that is properly situated in a Class 10,000 clean room which has a positive pressure differential relative to other phar-macy areas;
• Or prepared in a properly main-tained and monitored Class 100 clean room (without a hood).
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Pharmacy
Clean Room
• Each air-controlled area must have a positive pressure differential of at least 0.05" of water relative to adjacent areas that are less clean. Terminally-Sterilized Solutions should be prepared in a Class 100 laminar flow hood situated in a Class 100,000 control area. • The support area (anteroom)
adjacent should meet Federal Standard 209E Class 100,000 requirements and should be sepa-rated from the critical area by a barrier (for example, a plastic curtain, partition, or wall).
Enforcement of Guidelines
Clean rooms found in pharmacies may or may not be certified or built to meet the TAB recommendations. Customer opinion on this issue varies widely. The final decision is up to individual pharma-cies. The Pharmacy Manager should consult with the state board of pharmacy (the organization responsible for licensing of pharmacy operations) in making this decision. It is up to the board of pharmacy in each state to interpret guidelines, determine if they will be followed, and how (and if) they will be enforced.
Anteroom Description and
Activities
The anteroom is critical to meeting TAB recommendations because it forms a protective perimeter around the clean room. Herman Miller workstations and cart products are used in the anteroom more often than in the clean room. The anteroom is usually located adjacent to the clean room. Its key function is to create an area in close proximity to the clean room where technicians perform support tasks. This support perimeter reduces the risk of contamination in the clean room. The anteroom may also require a clean room rating (usually Class 100,000) depending on the risk level of sterile products being prepared in the critical area.
Pharmacy
Clean Room
In general the TAB recommends that particle-producing activities be per-formed in the anteroom. These activities include:
• Removing IV solutions and supplies from manufacturers’ packaging. Packaging should be removed in the anteroom and not be allowed in the clean room
• Order processing, order checking • Computer entry, generating labels
and affixing them to orders • Hand scrubbing and gowning • Bulk supply storage
The only items typically stored in the clean room are supplies used in the sterile preparation process. Ampules, additives, supplies, and large quantities of IVs are usually stored in the ante-room. Sinks, computers, and printers should be placed in the anteroom, not in the clean room.
The anteroom also handles sterile-product distribution from the clean room to all other pharmacy and user areas. Herman Miller carts can be used for this purpose.
Herman Miller Process Tables and L Carts can be used for order checking. These products facilitate cleaning because they are easy to move. Workstations can be created with work surfaces on Herman Miller Support Panels, Lab Modules, or Wall Strips. SM-Series Shelves create inclined storage space and Wire Carts can be used for bulk storage.
Material Transfer Between Anteroom and Clean Room
Controlled material transfer is critical for sterile products at risk Level 2 and Level 3. Pass-through modules allow such transfer without compromising air quality.
The pass-through is basically an airlock with two gasketed, transparent acrylic doors — one opens to the clean room, the other to the anteroom. Typical dimensions range from 18" wide by 18" high (457mm by 457mm) to 24" wide by 48" high (610mm by 1219mm). Typical depth is 18" (457mm) to 30" (762mm). The pass-through is usually installed at standing height — 48" (1219mm) — in the wall between the clean room and anteroom. A shelf in the pass-through facilitates transfer traffic. The shelf may receive incoming orders for sterile preparation; the lower area may receive completed orders ready for return to the anteroom and further distribution. Herman Miller Subcontainers can contain and organize these sterile preparation orders. Subcontainers removed from the pass-through can be placed on a Process Table for clean room transfer and parking at the airflow hood.
Considerations for Planning
and Design
Clean Room Construction Methods
There are many ways to construct clean rooms and clean areas.
Modular or Retrofit — Both are built with prefabricated materials/components. This is the construction method where Herman Miller can be most helpful. Herman Miller has an alliance with V-Wall, a modular floor-to-ceiling wall system that has been used to create certified Class 10,000 clean rooms. V-Wall modular systems have several advantages: they can be reconfigured for later use; they accommodate modular or hardwired electrical power; and they integrate with CO and AO components. Complete V-Wall information is listed later in this document.
Drywall — More or less a custom application. Most costly, least flexible, and takes the most time to build; also the most disruptive, dusty, and dirty. Softwall — A clean room environment constructed with vinyl walls (curtains); can also be mounted on wheels. Microenvironment — A specific cabinet built for a workstation that separates the technician from the product. This may be a tabletop model that is not a good solution for high volumes of sterile-product preparations.
Allocated Space
In conjunction with the Herman Miller Sales/Design team, the Pharmacy Manager should conduct a complete analysis of the work process flow to determine the most efficient allocation of space for the clean room and the ante-room.
As the Herman Miller representative you can assist the pharmacy in this space analysis. Gain an understanding of the types of products that will be prepared and their associated risk levels. How will materials move in and out of the clean room, and how many pass-through module locations will be required? Will an anteroom even be needed? Identify the necessary activities, number of people, location where the activities will be performed, and how much space will be required to support these activities.
Clean Room Size
The size of the clean room depends on the volume and risk level of IVs and the types of medications prepared each day. This affects the number and type of hoods needed (horizontal and/or verti-cal), the personnel requirements, and space allocation.
Position laminar flow hoods away from excess traffic, doors, air vents, or any disturbance that produces air currents capable of introducing contaminants into the hood.
Pharmacy
Clean Room
When determining the size and layout of the clean room, identify the quantity, type, and location of air filters required to meet clean room classifications. Clean Rooms International (CRI) is a company that can be helpful in this determination. CRI’s contact information is listed later in this document.
Supply Management
Determine where the supplies (IVs, syringes, additives) will be stored and understand the transport requirements. Large quantities of IVs, piggybacks, and other supplies will be used throughout the day. These items need to be stored conveniently near the clean room without compromising sterile preparation.
Operational Management
Consider the continuation of existing pharmacy operations during the con-struction stage. How will the transition from the old to the new space be executed?
Understand the nature of the work operation in the clean room. Are there slow and busy times? Is it open 24 hours? How can we provide effective solutions during the slow and busy times and increase productivity during peak hours?
Determine the risk level of the most commonly prepared medications. What clean room classification is required — Class 100, 10,000 or 100,000? Should the clean room be closed off from the rest of the pharmacy?
An environmental testing or certifying agency will need to be identified in order to obtain clean room certification and to establish continual room monitoring. Once these parameters are established, determine the specifications for lighting, temperature, humidity, and noise. At this stage, you can bring in Clean Rooms International to consult with the end user and determine these specifications.
Allocation of Responsibilities
Early in the process it is very important to identify those who will be involved in designing and building the clean room — architects, hospital maintenance engineers, the pharmacy department, and outside clean room contractor(s). In all probability the entire project will be managed by the Pharmacy Manager. Herman Miller’s opportunity is to be a resource to the Pharmacy Manager. Many people — and many suppliers — will be involved in planning and design. Though Herman Miller is a small part of the entire process, you may leverage other suppliers (such as V-Wall) through your involvement.
Usually the clean room manufacturer, such as Clean Rooms International, will: • Determine the number of air
exchanges needed per hour to achieve the desired clean room classification
• Discuss what types of light levels are required
• Recommend appropriate lighting and ceiling fixtures
• Determine the acceptable noise levels
• Determine necessary HVAC requirements (heating, air condition-ing, humidity).
There will be a number of miscellaneous items also required in the clean room that are outside of Herman Miller’s typical product package. Requests for these products should be directed to a clean room supplier such as CRI.
Design Requirements
The following is a useful list of questions to determine design requirements: • What risk level or clean room
classification is needed? • Is positive air pressure required? • How will the clean room be
sepa-rated from other areas in the pharmacy?
• How many and what types of hoods will be required? Where will they be located?
• Where will supplies, IVs, additives, ampules and other injectable medications be stored? In the clean room or anteroom?
• How many people will work in the clean room? In the anteroom? • How will supplies and sterile
preparations be transported between the anteroom and clean room? • How many and what types of
pass-throughs are required?
• How will sterile preparations be transported to the hospital floor? • How will biohazard waste be
handled?
• What are the ceiling and lighting specifications?
• Will the clean room be certified and continually monitored for air quality? What agency will be used? • Are security measures required?
How will access be limited to authorized personnel only? • How many hours per day will the
clean room be in operation? When are the peak hours?
• How will pharmacy operations be maintained during the construction phase?
• How will HVAC issues be addressed?
Pharmacy
Clean Room
Typical Installations
The following three plan views represent typical anteroom and clean room installations. The three views are variations based on the same architecture of structural walls. The structural walls are shown in solid black lines; open lines represent V-Wall Modular Wall construction.
There are many configurations for anterooms and clean rooms which will comply with ASHP Guidelines. The plan views presented here are for discussion purposes; they illustrate three examples of possible designs.
All the clean room examples are shown as Class 10,000 or 100,000. Actual requirements may vary based on the risk level need.
Pharmacy
Clean Room
Plan View 1
Anteroom
This plan view is drawn for a pharmacy requiring high-volume sterile prepara-tions at the highest risk level — Risk Level 3.
The anteroom is certified at Class 100,000 and is separated from the main pharmacy by an airlock. A sink unit is situated near the airlock for pre-passage scrubbing.
Pass-through refrigerators allow for bulk IV transfer. Sinks and waste disposal are confined to the anteroom.
Herman Miller workstations create the Administrative Area which supports computer use, order printing, order processing, patient profile review, and labeling. This area also stores reference material. Herman Miller flipper doors used here should be vinyl-surfaced for ease of cleaning.
The Order Assembly and Checking Areas use Process Tables that can be rolled away for easy floor cleaning. Process Tables can also be easily rearranged to increase productivity as work flow needs change.
Herman Miller carts can be used for bulk storage of IVs. They can also be situated to transfer materials within the anteroom and to the clean rooms. Wire Carts can exit the anteroom through the exterior airlock for sterile-product distribution to the floor.
Herman Miller recommends the use of a moveable wall system such as V-Wall Modular Walls. V-Wall easily facilitates future room design changes. Because the wall panels are removable, V-Wall provides a convenient solution for accessing or removing the laminar flow hoods for repair or replacement.
Clean Room
The air exchange rate inside this room is approximately 65X/hour. Two additional airlocks provide air quality protection. The first airlock opens to a convenient changing room for gowning with a Locker for garment storage.
Within the second airlock is a bench where technicians exchange shoes or place booties over street shoes. A second function of the bench is to block
unauthorized passage of material. The bench is hinged and can be swung out of the way to allow cart passage.
Inside the clean room are two Class 100 airflow hoods. The hoods are supplied by two pass-through modules; materials are carried on an L Cart. The Wire Cart provides transport and bulk supply storage of stock solutions.
For seating, Herman Miller recommends chairs and stools with vinyl upholstery for all clean room and anteroom areas. Vinyl offers the best solutions for cleaning.
