TABLE OF CONTENTS
Section No. | Title | Page No. |
1 | Table of Contents | |
2 | Introduction | |
3 | Objective | |
4 | Purpose | |
5 | Responsibility | |
6 | Qualification Procedure and Acceptance Criteria | |
7 | Change Control / Qualification Criteria | |
8 | Conclusion and Summary | |
9 | Final Approval | |
10 | Abbreviations | |
11 | List of Annexure |
INTRODUCTION
The compressed air system consists of a compressor dryer, storage tank, and distribution system equipped with an oil & moisture trap system. The compressed air system in the facility is to be validated as per this protocol.
OBJECTIVE
To provide documented evidence to demonstrate that the Compressed Air System when operated as per established standard operating procedure shall perform effectively & the compressed air coming in direct contact with the product during production & packing shall be in compliance with the established standard.
PURPOSE
This protocol is applicable for the performance qualification of the compressed air system installed at XYZ Ltd.
RESPONSIBILITY
- Engineering Officer shall be responsible for the preparation and execution of protocol & compilation of results.
- The Engineering Manager and Production Manager are responsible for checking protocol and complied reports.
- The quality Assurance Manager is responsible for the approval of protocol & complied reports.
QUALIFICATION PROCEDURE AND ACCEPTANCE CRITERIA
- Selection user points for qualification
- Critical points-Those points where the air comes in contact with the product/ primary packing components.
- Non-critical points- Those points where air does not come in contact with the product/ primary packing components.
- Only critical user points will be considered for qualification.
- List of equipment where compressed air comes in direct contact with the product/primary packing components.
Sr. No. | Equipment Liquid Washing | Location | ID. No. | Sampling Point |
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- Sampler & sampling procedure.
- Testing procedures for Compressed Air.
NOTE: Sampling and testing shall be performed in-house or outsourced approved agency.
Dew Point Test
- Set up the assembly for Dew Point Determination / Water / Vapor or Dew point transmitter.
- Install a reducer pressure with a gauge and flow meter to a point of monitoring and adjust the flow meter.
- Set the flow rate of compressed air to 100ml/minute for the tube method and 100L/min for a transmitter.
- Pass the compressed air through the Gastec Dew Point determination tube for 10 minutes. And in the case of the transmitter adjust the transmitter in front of the flow.
- Observe the tube immediately for the color change from yellow to purple Dragger tubes and in the case of the transmitter record the results.
- Perform the Dew Point determination test at identified locations as per Table-I and record in Annexure-II.
Oil Mist Test
Carry out the Oil Mist Test following either Method I or Method II.
A. Method I (Gastec Tube Method)
- Set up the assembly for oil mist determination (Make: Gastec Corporation, Japan, Principle: Dragger tubes).
- Set the flow rate of compressed air to 1 Liter/minute.
- Pass the compressed air through the Gastec oil mist determination tube for 20 minutes.
- Observe the tube immediately for the color change from pink to blue for oil and pink to yellow for water if present.
- Record the observation in the observation table.
- Carry the test for all the identified locations.
- Perform the oil mist determination test at identified locations and record it in Annexure-III.
B. Method II (Filter Paper Method)
- Set the flow rate of compressed air to 1 Liter/minute.
- Purge the compressed air through the purified water container for 5 minutes.
- Close the container and transfer it to QC/ Micro Lab.
- Filter the purged purified water through Cellulose Nitrate (0.45μ) Filter paper.
- Observe the Filter paper carefully under a microscope.
- Record the observation in the observation table.
- Carry the test for all the identified locations.
- Perform the oil mist determination test at identified locations and record it in Annexure-III
Non-Viable Particle Count Test
- Tests shall be performed in-house or by an external agency competent to carry out the testing and the reports in their formats shall be provided by the agency. Such reports shall be considered raw data and compilation shall be carried out by the engineering/ validation department.
- Set up the assembly for calibrated particle count (instrument make: Met One or equivalent, Principle: Light scattering).
- Connect the compressed air through the PU tube to the Clean ss Three-way Assembly and open the valve of compressed air.
- Allow the air to pass on for 1-2 minutes to flush the assembly.
- Connect the particles counter to assembly from the large opening side and start the particle counter.
- Take the particle count for 1 minute for particle sizes of 0.5μ and 5.0μ. (Sampling volume 1CFM ± 0.1).
- Record the observation in the observation table.
- Carry out the test for all the identified locations and record it in Annexure-IV.
- Perform the particle count test at identified locations.
Total Microbial Count Test
Carry out the microbial following either Method I or Method II or Method Ill.
A. Method I
- Sterilize the SS assembly & sieve.
- Connect the SS assembly's one side with a compressed air point and connect the SS assembly on another side with the M air T sampler.
- Operate the Milli pore Air sampler (Model: M air T) for operation and determination of microbial count.
- Pass 1 m3 (1000 liter) of compressed air over the Petri plates, using Soybean Casein Digest Agar (SCDA) plates.
- Incubate the plates at 30-35°C for 72 hours for Bacterial count & transfer the plates to 20-25°C for the next 2 days for fungal/ Yeast count.
- Record the observation in the observation table.
- Carry the test for all the identified locations and records.
- Perform the microbial count test at identified locations and record it in Annexure-V.
B. Method II
- Determine the viable volume of airflow discharge through, the user point, bypassing the compressed air for 60 seconds, in an inverted measuring cylinder filled with water. Record the volume of water displaced (Z ml). The volume of air for 5 minutes is calculated as V in m3 = (Z X 5) / 1000.
- Set up the air collection chamber and expose the sterilized Petri dish inside the chamber.
- Bleed off the compressed air into the chamber for 5 minutes so that compressed air passed over the media.
- Incubates the plates at 30-35°C for 72 hours for Bacterial count & transfer the plates to 20-25°C for the next 2 days for fungal I Yeast count.
- Determine the TMC by counting the number of colonies.
- Record the observation (as TMC) in the observation table. TMC per m3 is obtained from the value by V.
- Carry the test for all the identified locations and records.
- Perform the microbial count test at identified locations and record it in Annexure-V.
C. Method III
- Open the air valve to allow air to pass out for about 2 minutes to remove stagnant air in the line. Attach the clean sterilized silicone tubing to the user point.
- Open the air valve to bubble the air into 100 ml of sterilized Milli Q water by allowing air to pass to the tubing for about 2 minutes.
- Visibly inspect the flask containing sterile water against a white & black background by shaking the tube at frequent intervals to check the presence of suspended contaminants. Water should be free from suspended contaminants.
- Immediately bring the flasks after bubbling the air in the microbiology laboratory. Perform the analysis by membrane filtration.
- No growth should be observed in the Medium after incubation for five days.
CHANGE CONTROL / QUALIFICATION CRITERIA
If there is an Updation/modification in the Compressed Air System or if it is replaced by a new one, then qualification shall be carried out through a change control system.
CONCLUSION AND SUMMARY
- Compressed Air System shall be considered to be qualified for the performance, provided it shall meet the acceptance criteria for the same.
- The results of the Performance qualification shall be summarized in a summary report & the report shall be prepared by Quality Control as per Annexure-VI.
- After the evaluation of details and summary reports the Quality assurance and Production Head will be responsible for approval of the performance of the system.
FINAL APPROVAL
Final approval shall be prepared after completion of the Performance qualification of the Compressed Air System as per Annexure-VII.
ABBREVIATIONS
CFM: Cubic Feet Per Minute
cGMP: Current Good Manufacturing Practices
PPM: Part per million
EC: European Commission
PIC: Pharmaceutical Inspectorate
CFU: Colony Forming Unit
NLT: Not Less then
TMC: Total Microbial Count
LIST OF ANNEXURES
Annexure – I: Test Performance For Dew Point Test
Annexure-II: Test Performance For Oil & Mist Test
Annexure – III: Test Performance For Water Contents
Annexure-IV: Test Performance For Non-Viable Particle Count Test
Annexure – V: Test Performance For Viable Count Test
Annexure – VI: Summary And Conclusion
Annexure-VII: Final Approval
Tags
Qualification
