Step Operation Results Performed by: Supervised by
E-cell system regeneration
Stabilize the flow of concentrate:
Inlet Pressure from 0.3 to 0.6 bars Outlet Pressure from 0.3 to 0.6 bars
Manual Yes
No
Date / Sign. Date / Sign.
E-cell system regeneration
Adjust the flow of
purge concentrate Manual Yes
No
Date / Sign. Date / Sign.
E-cell system regeneration
Verification of suitability of flow rates and pressures
Manual Yes
No
Date / Sign. Date / Sign.
E-cell system
regeneration Starting the rectifier Manual Yes
No Date / Sign. Date / Sign.
E-cell system regeneration
Water quality and flow (parameters shown at PLC) are suitable
Manual Yes
No
Date / Sign. Date / Sign.
Normal Start
Press button:
Normal Start Enter Password
Manual
Yes
No Date / Sign. Date / Sign.
Normal Start
Confirm the password for the computer and the
screen
Automatic Yes
No
Date / Sign. Date / Sign.
Normal Start
Message appears:
NORMAL OPERATION
Automatic Yes
No
Date / Sign. Date / Sign.
Normal Start Operation of UV
Lamp Manual Yes
No Date / Sign. Date / Sign.
Normal Start Correct
Pretreatment Cycle Automatic Yes
No
Date / Sign. Date / Sign.
Normal Start Correct
Osmosis Cycle Automatic
Yes
No Date / Sign. Date / Sign.
Normal Start Correct Water Cycle
of Refinement Automatic
Yes
No Date / Sign. Date / Sign.
Normal Start
Correct water return to sanitization and
cleavage tank
Automatic Yes
No
Date / Sign. Date / Sign.
Annex B ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 4 / 8
Alarms Detected:
Date / Signature:
Remarks:
Date / Signature:
Results and conclusion:
Number of Positive responses:
Number of Negative responses:
Conclusion*:
*The test is considered valid only if all the questions are positive.
Performed by:
Date / Signature
Supervised by:
Date / Signature
Annex B ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 5 / 8
TABLE 2
Starting and operating of distribution and sanitization after stoppage
Step Operation Results Performed by: Supervised by
Starting
Verify that all the points of use are
closed. Manual Yes
No
Date Date
Starting
Verified that storage
tank valve is closed. Manual Yes
No
Date Date
Starting
Verify that all the pumping and intaking valves are
closed.
Manual Yes
No
Date Date
Starting
Verify that purifying
system is operation. Manual Yes
No
Date Date
Starting
Verify the availability
of comprised air. Manual Yes
No
Date Date
Starting
Verify the availability
of electric power. Manual Yes
No
Date Date
Starting
Turn off the general switch in the electric
frame. Manual Yes
No
Date Date
Starting
Release emergency
stop. Manual Yes
No
Date Date
Starting
Connect all the switches and fuses
in electric frame. Manual Yes
No
Date Date
Starting Verify screen is on.
Manual Yes
No Date Date
Starting Press button:
CONSIGNAS. Manual Yes
No Date Date
Starting
Verify that operating parameters shown in
the screen are correct and no alarms are shown.
Manual Yes
No
Date Date
Starting
Press button:
AUTOMATICO. Manual Yes
No
Date Date
Starting
Press button:
MARCHA LOOP. Manual Yes
No
Date Date
Starting
Verify that water is entering in storage
tank. Automatic Yes
No
Date Date
Annex B ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 6 / 8
Step Operation Results Performed by: Supervised by
Starting
Verify the correct level of water for
pumping starts. Automatic Yes
No
Date Date
Starting
Pumping system
starts. Automatic Yes
No
Date Date
Starting
Speed of water
return is regulated. Automatic Yes
No
Date Date
Starting UV lamp starts.
Automatic Yes
No Date Date
Starting
Valves at points of use operate
correctly. Automatic Yes
No
Date Date
Starting
Valves at sampling points operate
correctly. Automatic Yes
No
Date Date
Sanitization
Verify the operating program is:
AUTOMATICO Manual Yes
No
Date Date
Sanitization
Verify the system is
operating. Manual Yes
No
Date Date
Sanitization
Verify that no consume is any
point of use. Manual Yes
No
Date Date
Sanitization
Verify availability of cool water and
steam. Manual Yes
No
Date Date
Sanitization
Verify valves at steam entrance;
condenser returns;
cool water entrance and cool water return are open.
Manual Yes
No
Date Date
Sanitization
Start sanitization
program. Manual Yes
No
Date Date
Sanitization Confirmation.
Automatic Yes
No Date Date
Sanitization
Storage tank draining.
Valve in storage tank is in draining
position.
Automatic Yes
No
Date Date
Sanitization UV lamp starts.
Automatic Yes
No Date Date
Annex B ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 7 / 8
ETAPA ACCIÓN CONFORMIDAD REALIZADO VERIFICADO
Sanitization Purge
Automatic Yes
No Date Date
Sanitization Heating
Automatic Yes
No Date Date
Sanitization
Water is maintained hot during
sanitization. Automatic Yes
No
Date Date
Sanitization Purge.
Automatic Yes
No Date Date
Sanitization Cooling.
Automatic Yes
No Date Date
Sanitization
Water is at operating
temperature. Automatic Yes
No
Date Date
Normal operation
Water is available at
every point of use. Automatic Yes
No
Date Date
Annex B ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 8 / 8
Alarms Detected:
Date / Signature:
Remarks:
Date / Signature:
Results and conclusion:
Number of Positive responses:
Number of Negative responses:
Conclusion*:
*The test is considered valid only if all the questions are positive.
Performed by:
Date / Signature
Supervised by:
Date / Signature
Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 1 / 29
Sampling Control and Data Record
TABLE OF CONTENTS
1. Introduction
2. Sampling record template
3. Analytical data record template
PREPARED BY:
Date and signature
SUPERVISED BY:
Date and signature
APPROVED BY:
Date and signature
Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 2 / 29
1. INTRODUCTION
A very important part of Performance Qualification step of this purifying water system involves sampling and testing of water along the whole production and distribution.
This annex covers and compiles sampling, codification of samples, acceptance criteria and obtained results.
In table below is summarized considered sampling points; their location their identification and the quality desired in each one.
During the first step of this qualification study, every point listed below should be sampled during 20 days. After this step and whenever no critical deviation or failure of the system occurs, only critical points (marked in bold) will be tested during a whole year of worth data.
Annex C ERCROS 02/12 Validation Protocol – Rev. 1 Pag. 3 / 29
Sampling sketch
Sampling point Identification Location Quality
Purifying Plant
VHB 001 VHB 001 Incoming feed water Potable water
VHD 003 VHD 003 After 1.5 mc microfiltration unit Potable water VHD 007 VHD 007 After reverse osmosis system Osmotic water VHD 010 VHD 010 After electrodesionization
system
Purified water
VHD 011 VHD 011 After UV lamp UVA Purified water
Storage and Distribution
SV 541 001 SV 541 001 After storage tank and before
Intake drainage valve at
DC-0502-00 reactor Purified water DC-0501-00
Reactor PU-4
Level 2.
Intake drainage valve at
DC-0501-00 reactor Purified water DC-0504-00
Reactor PU-3 Level 2.
Intake drainage valve at
DC-0504-00 reactor Purified water DC-0507-00
Reactor PU-2 Level 2.
Intake drainage valve at DC-0507-00 reactor
Purified water
DC-0508-00
Reactor PU-1 Level 2.
Intake drainage valve at
DC-0508-00 reactor Purified water DF-0532-02
DF-0532-03