September 7, 2016 LATEST NEWS Performance Qualification Protocol of Tunnel Sterilizer Search...

Home Production QA & QC Engineering Warehouse Validation & Qualification Media And Video Guideline Contact Us Jobs

YOU ARE AT: Home Validation & Qualification Qualification Performance Qualification(PQ) PERFORMANCE QUALIFICATION PROTOCOL OF WATER FOR INJECTION
GENERATION AND DISTRIBUTION SYSTEM

FOR FREE UPDATE

Email *

Subscribe

PERFORMANCE QUALIFICATION PROTOCOL OF WATER FOR INJECTION 0

GENERATION AND DISTRIBUTION SYSTEM

BY PHARMACEUTICAL GUIDANACE ON JULY 18, 2016 PERFORMANCE QUALIFICATION(PQ), VALIDATION & QUALIFICATION

Regstrese

Document No.

Supersedes

Effective Date

Review Date

No. of Pages
FACEBOOK

Reference Protocol No.

Protocol Contents

1.0 Protocol Approval
2. Overview
2.1Objective:
Like Page Share
2.2 Purpose and Scope
2.3 Responsibility Be the first of your friends to like this

2.4 Qualification Team

3.0 Traning Record
3.1 Purpose
3.2 Scope
4.0 Performance Qualification Requirements
5.0 System / Equipment Description
5.1 System / Equipment details
5.2 Design
6.0 Performance Qualification Procedure
7.0 Re- Validation Critaria NIST-Traceable Biotest ErgoTouch
Calibration; Air/Ga Pro 2 Airborne Part
8.0 Acceptance Criteria
9.0 Qualification Report
10.0 Observed Deviation
11.0 List of Exhibits/Annexure
FIND US ON GOOGLE PLUS
11.1 List of Exhibits
11.2 List Annexure
12.0 Reference Documents
Protocol Approval
This is a specific protocol for Performance Qualification of Water for Injection generation, Storage,
Distribution System.
This protocol has been approved by the following:
 Name Department Signature Date

Prepared By

Checked By

Approved By

Final Approval:
Final approval has been given by the following:

Name Signature Date

Pharmaceutical Guidance
Approved By
Seguir
(Plant Head)
92 seguidores
Approved By
(Head QA)

Overview:
Objective:
To establish the methodology for the Performance Qualification of WFI Generation, Storage and
Distribution system (ID.NO: ______________), which produces pyrogen free, water for injection, used as a
Sterile products manufacturing facility.
Purpose and Scope
The purpose of this Protocol is to establish the performance Qualification of WFI generation, Storage and
Distribution system to:
Demonstrate that WFI System shall perform reproducibly and consistently with in its full dynamic
range of operation according to Functional / Manufacturers / In house specifications.
Document the initial performance of the WFI System for future reference.
Assure that the WFI System performance is adequate to support the method/methods for which
the system is intended.
Assure the accurate and precise results/observations of the substances being examined are
recorded.
Responsibility
Protocol / Report Preparation: Officer or above QC / QA
Protocol / Report Checking: Manager QC / Nominee
Execution of Qualification Activity: Officer or above QC / QA
Protocol / Report Approval: Head QA
Final Approval: GM formulation / Head QA
The Production and Engineering Department shall be responsible for checking the operation. The Quality
Control shall be collecting the sample from the sampling points according to the sampling plan and
Quality Control shall carry out the tests as per the specifications and respective test procedures. The
Quality Control shall prepare the data trend for all the three phase of validation study. The summary
report of the Performance Qualification shall be prepared by Quality Assurance Department. Separate
reports will be prepared for phase-I, phase-II, and phase-III studies respectively.
Qualification Team
User Department Officer / Executive
Officer / Executive QA
Manager QA / QC
Training Record
Purpose
The purpose of the training is to familiarize the trainees with the principle of working & technical
specifications of WFI System as well as overall strategy of Performance Qualification of the WFI
Generation, Storage and Distribution System.
Scope
This Training is related to the Water for Injection generation, storage and distribution system and being
imparted to the people involved in the WFI water system validation.
Topics
The following topics to be covered during training:
Principle and operating of Water for Injection system.
Technical specifications of the system components.
 Overall strategy of Qualification process.
General precautions / guidelines to be followed during qualification.
Note:
Training is given as per SOP Title: SOP on cGMP Training
Training record have been attached with the report
Performance Qualification Requirements
Following reagents/ chemical/standards shall be required for the Performance Qualification of Water for
Injection system
Bottles for Sampling.
All test solutions.
Media
System / Equipment Description:
System/Equipment Details
Equipment Identification Number
Location
Name of the system/Instrument
Manufacturers Name
Model
Purchase Order Number
Date of Installation
Design
Working Principle:
The Water For Injection System Still is working on the Principle of inters stage heat exchange (Reuse of
energy) drastically reduce the consumption of heat energy and cooling water. Thus enable to produce
large- scale of Pyrogen free sterile water for injection. The Distillation Column operates at different
pressure and temperature making it possible to transfer the energy in process forward column to column.
Brief Instrument Description:
Water for Injection System produces pyrogen free, sterile water for injection which meets the
requirements of the international pharmacopeias including USP, BP, and IP. It operates on the distillation
as a unit process. Sterile water generation engross with Liquid-vapor-liquid phase change to produce very
high purity water.
Water for Injection system works on Falling Film Evaporator principle. It employs high temperature
which assures constant sterile water.
The unit design to remove microbial contamination by three stage separation. Number of effects is
connected in series. Each effect has a innermost evaporator (shell & tube heat exchanger), an
intermediate separator and outer column. Source of energy for this effect is boiler steam & the remaining
effects use the intrinsic heat to supplement consumption needs of the heating energy.
Feed water is pre heated by waste heat recovery method and enter the first effect from tube side.
Specially designed distribution plate ensures the water falls down the tube as a Thin film. The falling
film is heated with plant steam and causing it to instant flash evaporation. This flash evaporation helps
the steam to leave behind the heavier particles or droplets. (First stage of separation). This
transformation from water to steam significantly increases the velocity as it approaches the bottom of
the column with high pressure.
This vapor as it moves outside the tubes is forced to change its direction to a 180 turn. This directional
changes induces the separation of large water droplets (secondary separation), which fall into the bottom
of the column, where they are collected with excess feed water that has not evaporated.
As the steam moves upwards, the spirals provided on the shell of the evaporator forces the steam to
move in a circular path. The resulting centrifugal action forces the remaining microscopic droplets and
impurities including the Endotoxins to the outer surface, which then gets blow down through the windows
provided on the separator (Third stage separation).
Unevaporated water becomes the feed water & this process is repeated in all the remaining effects each
working at lower temperature & pressure than the one preceding it. Pure steam condenses as WFI in each
effects & WFI along with the pure steam from the last column is taken to the condenser where it is cooled
to 95 C by using cooling water.
Plant operates on PLC system. PLC system ensures efficient working of plant under favorable conditions.
In case of violation of any critical condition, plant will automatically stop & give audio-visual signal to
operator. When the problem gets solved, plant will start automatically.
System has unique feature of purging which remove water containing pyrogen and other impurities and
keep concentration of impurities to minimum level.
So, WFI produced from each column except first column will be collected at bottom of the column &
transferred to cooler. Steam, which is produced in final column, will also be taken to cooler, which will
convert into WFI.
Brief Description of Distribution System:
Control of WFI distribution loop and WFI storage tank will be through common PLC panel. Distribution of
WFI through various user point provided in the loop system. WFI is generated using Multicolumn and
stored in WFI storage tank at 85C to 90C. It is pumped into distribution loop using centrifugal pump.
One stand by pump is also provided. All piping is having Armaflex insulation with SS 304 cladding below
false ceiling and with aluminum foil above false ceiling.
The return loop to the WFI tank is having following instrumentation and control.
Flow Indicator and controller: It will indicate flow rate in the return line and will control the
minimum return flow rate to WFI tank using VFD of circulation pump.
Conductivity sensor and controller: Conductivity sensor will sense conductivity of WFI coming in
return loop and if conductivity is beyond the set point, it will drain all WFI.
Temperature sensor, Transmitter and Indicator: It will sense temperature of WFI in return line
and will indicate same.
Performance Qualification Procedure
The following procedure has been used for performance qualification of Water for Injection
generation, storage and distribution system:
Water for Injection System was checked for completion of the operational qualification activity.
The Performance Qualification of water system is proposed to be carried out in three phases
Performance Qualification Plan & Rationale:
Phase-I extensive sampling from Generation points & usage points for 1 month
Phase-II extensive sampling from selective generation & all usage points for 3 months
Phase-III routine sampling from usage points on rotation basis, for 8 months
The phase-I study shall be done as per procedure mentioned below. The observation of the study shall be
recorded as per the format provided in Exhibit-01.
The data sheets shall be attached date wise in Annexure-02.
After completion of phase-I studies the graphical representation of the data of all the parameters shall be
done individually and should attached in Annexure-04.
Phase I: (For a period of 1 month)
The performance qualification of Water for Injection System shall be started, when all the equipment and
piping of WFI system had been verified to be installed properly and operating correctly.
Phase-I of the performance qualification of Water for Injection System included extensive sampling of
WFI, from various points along with all the usage points of the distribution loops . The phase-I sampling
shall be carried out for a period of 1 month.
During this phase water samples from all generation / usage points shall be analysed and monitored for
compliance to the pre-determined specifications.
After successful completion of Phase-I of the performance qualification, the Water for Injection System
should be cleared for usage of WFI water in manufacturing operations. Purpose of Phase-I qualification is
to stabilize the operating parameters. Conclusions have been described in a summary form.
The phase-II studies shall be done as per procedure mentioned below. The observations of the
study shall be recorded as per the format provided in Exhibit-01.
The data sheets should be attached date wise in Annexure-04.
After completion of phase-II studies the graphical representation of the data of all the parameters
shall be done individually and shall be attached in Annexure-05.
Phase II: (For a period of 3 months)
Phase-II of the performance qualification shall be commence, after successful completion of Phase-I.
Purpose of Phase-II qualification is to monitor the operating parameters. The objective of Phase-II is also
to demonstrate that system is producing desired quality of water, on a consistent basis, when operated in
conformance with SOP established at the end of Phase-I. Conclusions shall be mentioned in Summary
report.
During Phase-II, WFI water samples shall be collected from various Sampling Points in generation system
as mentioned in sampling plan and Usage Points on a Daily basis. Phase-II of the performance
qualification of Water for Injection System include extensive sampling of WFI water from all sampling
points in the Water for Injection System & usage points of the distribution loops on daily basis. Phase-II
sampling carried out for a period of 3 month. Water samples from the all the usage points shall be
analysed and monitored daily, for compliance to the pre-determined specifications.
After successful completion of Phase-II of the performance qualification, the Water for Injection shall be
cleared for Phase-III.
The phase-III studies shall be done as per procedure mentioned below. The observations of the
study shall be recorded as per the format provided in Exhibit-01.
The data sheets should be attached date wise in Annexure-06.
After completion of phase-III studies the graphical representation of the data of all the parameters
shall be done individually and shall be attached in Annexure-07.
Phase III: (For a period of 8 months)
Phase-III of the performance qualification shall be commencing, after successful completion of
Phase-II. Purpose of Phase-II qualification is to monitor the operating parameters. The objective of
Phase-III is also to demonstrate that system is producing desired quality of water, on a consistent
basis, when operated in conformance with established SOP and does not have any seasonal
variation through out the Phase-III study to collect the robust data. Conclusions shall be mentioned
in Summary report.
During Phase-III, WFI water samples shall be collected from various Sampling Points in Water for
Injection System as mentioned in sampling plan and Usage Points on a weekly basis. Phase-III of
the performance qualification of Water for Injection System include extensive sampling of water
from various points in the WFI water generation system & all the usage points of the distribution
loops on weekly basis. Phase-III sampling carried out for a period of 8 months. Water samples from
the all the usage points shall be analysed and monitored weekly, for compliance to the pre-
determined specifications.
Specifications of Water for Injection:

S. No. Test Parameter Specification STP/ GTP code

A. Chemical Analysis

1. Description Clear colourless, odourless

and tasteless liquid

2. pH (at 25C) Between 5.0 to 8.0

3. Conductivity (at 25C) NMT 1.3 S / cm

4. Ammonium NMT 0.3 ppm

5. Calcium No turbidity observed

6. Chlorides NMT 0.50 ppm

7. Sulphates No turbidity observed

8. Total Organic Carbon NMT 500 ppb

9. Oxidisable Substance The solution remain faintly

pink

10. Carbon Dioxide The solution should remain

clear

B. Microbiological Analysis

1. Total Aerobic Microbial Count NMT 10 cfu / 100 ml

(TAMC)

2. Bacterial Endotoxin Test NMT 0.125 EU / ml

6.7 Sampling Plan & Frequency

S. Name of the Specification Sampling Room Phase 1 Phase 2 Phase 3

N. Sampling point Compliance point No. No. Sampling Sampling Sampling
frequency frequency frequency
/ Day

A WFI sampling points in Generation system

1. After Column II As per WFI WFI 01 NA Daily Weekly

 2. After Column III As per WFI WFI 02 NA Weekly

3. After Column IV As per WFI WFI 03 NA Weekly

Daily
4. After Column V As per WFI WFI 04 NA Weekly

5. After WFI As per WFI WFI 05 NA Weekly

Generation

6. Storage Tank As per WFI WFI 06 NA Daily

B Usage points in WFI Distribution loop system

7. Garment As per WFI WFI 07 Weekly

Washing Room Daily

8. Equipment As per WFI WFI 08 Weekly

Washing and
Sterilization
Room Daily

9. Vial Washing As per WFI WFI 09 Weekly

Room

10. Before Bung As per WFI WFI 10 Weekly

Processor

11. Return Loop As per WFI WFI 11 Daily

Daily
Evaluation of test results shall be done by comparison against the standard criteria.
Alert level and action level shall be established on the basis of Phase-I and Phase-II data.
Alert levels are levels or range that, when exceeded; indicate that a process may have drifted from
its normal operating condition.
Alert levels constitute a warning and do not necessarily require a corrective action.
Alert Level = Max. Count + 2 X Standard Deviation
Action levels are levels or range that, when exceeded, indicate that a process has drifted from its
normal operating range. Exceeding an Action level indicates that corrective action should be taken
to bring the process back into its normal operating range).
Action Level = Max. Count + 3 X Standard Deviation
Deviation observed during the Phase-I, Phase-II & Phase-III of performance qualification shall be
noted.
Re validation Criteria:
Performance Qualification of WFI Water System to be revalidated on:
Any major modification in the existing system including distribution loop since purchase, which
potentially could affect flow rates storage, delivery, sampling or water quality, or significant change
in the operational parameter.
If the system is found to be malfunctioning after any deviation / after any major breakdown
maintenance.
Relocation of the system.
Acceptance Criteria
Performance qualification shall be considered acceptable when all above requirements of this
protocol has been fulfilled and all the parameter is functioning as per the design specifications and
as per manufacturers recommendations.
Qualification Report
The performance qualification report shall consist of a summary document, in narrative form,
which shall briefly describe the activity performed along with the observations recorded in relevant
exhibits.
This report shall also include the related documents and attachments / annexure which were
completed at the time of qualification activity.
Observed Deviation

Sr. Page Point Observed Deviation Deviation Corrective Justification Corrective

No. No. No. Deviation Reported Approved Action of Corrective action taken
By By Taken Action and
justification
given by
List of Exhibits / Annexure
List of Exhibits

Exhibit No. Exhibit Title No. of Pages

01 Data sheet for PQ test results of WFI Water

Total No. of pages

List of Annexures

Annexure No. Annexure Title No. of Pages

01 Training Record

02 Data sheets of Phase-I

Graphical representation of Phase-I results

03 Data sheets of Phase-II

Graphical representation of Phase-II results

04 Data sheets of Phase-III

Graphical representation of Phase-III results

Total No. of pages

Reference Documents
Design Qualification
Installation Qualification
Operation Qualification.
United States Pharmacopoeia.
Indian Pharamcopoeia.
(Exhibit E01 )Data Sheet for PQ Test Results of WFI Water

System Name:
Sampling Point No.: Phase: I/ II/ III

Date ()

Test Parameters () Results

Description

pH (at 25C)

Conductivity (at 25C)

Ammonium

Calcium

Sulphate

Total Organic Carbon

Oxidisable Substance

Carbon Dioxide

Total Aerobic Microbial Count

(TAMC)

Bacterial Endotoxin Test

Sampled Chemical Analysis

By
Microbiological
Analysis

Chemical Analysis
Analysed Microbiological
By Analysis

Done By (Sign & Date)

Checked By (Sign & Date)

Approved By/Date:

Sharing

Regstrese

ABOUT AUTHOR

PHARMACEUTICAL GUIDANACE

RELATED POSTS

SEPTEMBER 3, 2016 1 AUGUST 22, 2016 0 AUGUST 21, 2016 2

Performance Qualification DESIGN QUALIFICATION OF BIN DESIGN QUALIFICATION

Protocol of Tunnel Sterilizer WASHING & DRYING SYSTEM CARTONING MACHINE HI CART
(BLISTER PACKING)

LEAVE A REPLY

Your Comment

Your Name

Your Email

Your Website

POST COMMENT

GO BACK

ABOUT RECENT POST SHARING

Pharmaceutical Guidance Performance Qualification Protocol of Tunnel Sterilizer

SOP on Quality Risk Management

Pharma Guidance is Indias online complete Pharma
solution platform, where people can connect with each
other to share knowledge, buy the required Pharma
related Document .The vision is to support the all
manufacturers of pharmaceutical company to prepared
the current and update document to complies the cGMP
norms and also give the updated knowledge to new
Pharma beginner.

Copyright 2016 - Pharmaceutical Guidance by Sainssoft Technology