sop for Performance Qualification Protocol for Bottle Washing Machine

PERFORMANCE QUALIFICATION PROTOCOL

1.0 APPROVAL:

1.1 This protocol is prepared by QA

Department	Quality Assurance
Signature
Name
Designation
Date

1.2 This protocol is reviewed by validation team

Department	Quality Assurance	Production	Engineering
Signature
Name
Designation
Date

2.0 TABLE OF CONTENT:

SR. NO.	CONTENT	PAGE NO.
1.0	APPROVAL

2.0	TABLE OF CONTENT

3.0	OBJECTIVE

4.0	SCOPE

5.0	VALIDATION TEAM AND RESPONSIBILITIES

6.0	PERFORMANCE EXPERIMENTAL PLAN

7.0	PREREQUISITES

8.0	PERFORMANCE EXPERIMENTAL PROCEDURE

9.0	ACCEPTANCE CRITERIA

10.0	REFERENCE

11.0	REQULAIFICATION CRITERIA

12.0	LIST OF ANNEXES

13.0	REVISION HISTORY

14.0	NON-COMPLIANCE AND CORRECTIVE ACTION

3.0 OBJECTIVE:
To prepare Protocol for qualification of bottle washing machine.
To provide documented evidence that the Equipment is performing as per the defined parameter and that it gives result as per the predetermined acceptance criteria.
To demonstrate that the system will operate reproducibly and consistently within its operating range.
To confirm the suitability of the Standard Operating Procedures for all routine activities associated with the system.
4.0 SCOPE:
This protocol covers all aspects of calibration activities for bottle washing machine in Liquid Syrup section at M/S pharma
This protocol defines the methods and documentation used to qualify bottle washing machine.
5.0 VALIDATION TEAM AND RESPONSIBILITIES:

5.1 Engineering:-
5.1.1 Providing the utility services
5.1.2 Recording and reporting the data as per PQ protocol
5.1.3 Review of final report
5.2 Quality Assurance :-
5.2.1 Preparation and Final review of PQ Protocol and final report
5.2.2 Its compliance to meet the acceptance criteria of the Performance Qualification protocol
5.2.3 Preparation and approval of final report
5.3 Production:-
5.3.1 Review of PQ Protocol and review of final report
5.4 Quality Control
5.4.1 Review of Protocol and Report
5.4.2 Sampling & Testing/ analysis

6.0 PERFORMANCE EXPERIMENTAL PLAN:

DESCRIPTION OF EQUIPMENT:

Equipment Name	:	Bottle Washing Machine
Make	:
Model No.	:
Equipment ID	:
Location	:	Liquid Syrup

The Rotary bottle washing machine is an continuous motion wash unit that washes new cylindrical containers, such as Bottle, unstable, conforming to specific standards operating system.
The various washing cycle combinations are:
a) Inside Raw water washing
b) Inside DM water washing
Set the bottle in a rotary for washing and set in the machine First raw water for washing to the bottle , DM water washing .
3000 bottle washed per hour .
USE OF EQUIPMENT:
The Bottle Washing Machine is designed to process pharmaceutical products in accordance with cGMP regulations and can be used for manufacturing of Liquid Orals Dosage forms.

Performance Qualification Test Plan :
1. Prerequisite activities and documentation.
2. SOP Verification.
3. Performance Test of Bottle Washing Machine.
7.0 PREREQUISITES:
7.1 Documentation
The following documents provide confirmation that the prerequisite for commencing execution have been completed, reviewed, and approved.

Document	Document Number	Location	Approved Pass / Fail	Initial / Date
Design Qualification`
Installation Qualification
Operational Qualification

Test Equipment Calibration Verification

Calibration of all measuring instrument / devices.

7.3 SOP Verification
The SOPs required for operation and maintenance of this system must be verified to be effective

to include amendments deemed necessary during execution of the PQ.

8.0 PERFORMANCE EXPERIMENTAL PROCEDURE:

Performance of the equipment shall be verified by simulating the normal operation for washing by
8.1 Pre qualification of Bottle Washing Machine
8.1.1 Check the operating parameters before starting the challenge Test.

Sr. No	PARAMETERS	STANDARDS
1	Water pressure	NLT 1.5 kg/cm²
2	Particulate matter	Free from particulate matter

8.2 Taking samples at the different speed and different hopper level.
8.3 Performance Challenges of Bottle Washing Machine
8.3.1 Test should be performed on all pack sizes, from pack size 100 & 200 ml.
8.3.2 Cleaning is largely dependent on bottle size, water spray time, and pressure a. So each size of the Bottle will be subjected to the PQ study. Preparation of Sodium Chloride spiking Bottle
8.3.2.1 Prepare a 20% Sodium Chloride into 1000 ml Purified Water.
8.3.2.2 Take 100 bottle of 100 & 200 ml each and add 0.5 ml of 20% Sodium Chloride solution into the
Bottle.
8.3.2.3 Agitate to the internal surfaces wet by the solution and dry them at 600 C for overnight.
8.3.2.4 Confirm the level of Chloride contamination using method specified in USP for Sodium Chloride
assay.
8.3.2.5 Number them with permanent marker resistant to washing for identification.
8.3.3 Spike the 75 bottles of 100 ml and 200 ml each
8.3.4 Operate the Rotary bottle Washing Machine as per SOP No. .
8.3.5 The quantity of bottle to be washed is the same as normal production size to demonstrate the performance of the normal process.
8.3.6 Those 24 contaminated Bottles are divided into three groups. The first group is put at the beginning of the washing process, the second group is put in middle of the process randomly, while the third group is schedule at the end of the washing process. Each group contained eight contaminated Bottle washed on each washing channel. To ensure each washing channel will be challenged and easy to analyze in the case of failure, these contaminated testing Bottle were marked consecutively, and deliberately arranged
8.3.7 Washing cycle should be carried for 30 minutes.
8.3.8 The washed contaminated Bottle were carefully collected with gloves and placed into identified, particle-free cleaning bags as they exited the washer.
8.3.9 Collected Bottle shall be sent to the laboratory for testing.
8.3.10 Collect the random washed Bottle for any particulate contamination.
8.3.11 Note down the results of Sodium Chloride Challenge tests on Annex-II.
8.4 Repeat whole exercise for 200 ml as per 8.2.4 to 8.2.11.

8.5 Each study was challenged three times to verify the reproducibility of the machine’s performance.

9.0 ACCEPTANCE CRITERIA

Chemical Challenge Studies : Testing Bottle for the chemical decontamination study are all free of sodium chloride.
Testing Bottle for particle contamination study were all free of particles.

10.0 REFERENCE

Equipment manual.
Schedule – M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”

11.0 REQULAIFICATION CRITERIA :
Performance Qualification of System to be re-qualified
• Substitution of existing equipment with new equipment.
• Any major modification in existing equipment since purchase or after the last performance qualification, which must be properly documented through a change control system.
• Adjustments made in the instruments, to correct the non-compliance of results.
• Five Years from the date of last qualification/re – qualification performed.

12.0 LIST OF ANNEXES: NILL

13.0 REVISION HISTORY:

Revision

No.

Reason for

revision

Changes Incorporated

New Protocol

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