Weighing room validation document

Introduction

This equipment verification targets the negative pressure weighing hoods used in aerosol workshops. Specific specifications and models are shown in the table below:

Name	Model	Serial No.	Manufacturer	Installation site
Negative pressure weighing hood	——	01-02-12	SUZHOU BOBEN PURIFICATION TECHNOLOGY CO.,LTD	Weighing room

• Verification Scope
  • Operation Verification: Test all equipment functions by running the equipment at no load to confirm that all components are in good condition and can meet all designed performance indicators.
  • Performance Verification: Verify that the equipment can meet Class D requirements under normal operation.

• Verify the organizational structure and division of responsibilities among personnel

2.1 Verification Leadership Group

Dept.	Name	Position	Scope of Responsibilities
Biotechnology		Biotechnology dept. manager	Review of system verification plans and reports; organization and implementation of verification
Quality Control		Quality Control dept. manager	Review and confirm the technical and quality aspects of system verification plans and reports, and approve verification plans and reports

2.2 Verification Implementation Team

Dept.	Name	Position	Verify job title
Biotechnology		Biotechnology dept. manager	Team Leader
Equipment		Assistant Manager	Deputy Group Leader
Aerosol Workshop		Equipment Administrator	Team members
		Equipment Administrator
		Assignment of squad leaders
laboratory		laboratory technician

• Verify implementation progress and personnel arrangements

Verification phase	Implementation time	Participants
Operation confirmation
Performance Confirmation

• Verification Basis

1. Pharmacopoeia of the People’s Republic of China, 2015 Edition

2. Good Manufacturing Practice for Pharmaceuticals, 2010 Edition

Cleanliness level       Item		Level D
Dust particlesNumber of particles/m3	≥0.5μm	≤3520000
	≥5μm	≤29000
Planktonic bacteria  cfu/m		≤200
sedimentation bacteria（f90mm） cfu /4小时		≤100

• Verification Content
• Operation Verification
  • Computer System Security Check

Due to inherent system vulnerabilities, the system cannot set user permissions and passwords. In this case, check for written records and other physical isolation measures. See Appendix 1 for the inspection results.

• Computer System Control/Operation Verification

Confirmation Method: After confirming that the external power supply and operating parameters are within the specified range, click the corresponding operation button on the screen to manually control the system.

Acceptance Criteria: Upon manually clicking the corresponding operation button, each system unit immediately responds, such as turning the fan on and off, turning the lighting on and off, and adjusting the operating frequency. Finally, the system is able to enter normal operation.

See Appendix 2 for the inspection and confirmation results.

• Computer System Display Accuracy Verification

Confirmation Method: Turn on the lights and fans, and after the system is operating normally, check the relevant operating parameters.

Acceptance Criteria: After normal operation, the filter differential pressure display meets the standard and is correct, and the fan rotation direction is consistent with the interface diagram.

See Appendix 3 for the inspection results.

• Data integrity confirmation

Confirmation method: During operation, disconnect the power supply and observe the operation of the PLC system and the entire system, and the preservation of the PLC program and the set parameters. Then restore the power supply and observe the system recovery.

Acceptable standard:

1. After disconnecting the power supply, the PLC control system stops running and the entire system stops running at the same time;
2. After restoring the power supply, the program and the set parameters are not lost;
3. The inspection and confirmation results are shown in Appendix 4.

• Document applicability confirmation

Qualification standard: Applicable to the operation and maintenance of workshop air-conditioning units and the inspection of the cleanliness of clean areas.

Confirmation method: Carefully check the relevant documents and operate and inspect according to the regulations to confirm the applicability of the documents.

The inspection and confirmation results are shown in Appendix 5.

• Wind speed confirmation

Qualification standard: The wind speed qualification standard is 0.36-0.54m/s.

Confirmation method: Use an anemometer to test the wind speed 30cm below the filter, and evenly select 5 points to measure the wind speed.

The inspection results are shown in Appendix 6.

• Leak Test

Qualification Criteria: Filter and frame leakage rate less than 0.01%.

Verification Method: Use the ATI HEPA filter leak tester to test each filter.

See Appendix 7 for inspection results.

• Illumination Verification

Qualification Criteria: Illumination greater than 360 lux.

Verification Method: Perform an illumination test on each weighing hood.

See Appendix 8 for inspection results.

• Noise Verification

Qualification Criteria: Noise level less than 75 dB.

Verification Method: Open the weighing hood, test two points, distribute the noise evenly, and measure the noise level using a sound level meter.

See Appendix 9 for inspection results.

• Airflow Verification

Qualification Criteria: Unidirectional flow, no backflow.

Verification Method: Open the weighing hood, operate it normally, generate smoke with a smoke pen at the weighing area, and observe the smoke flow lines.

See Appendix 10 for inspection results.

• Confirmation of Self-Purification Time

Qualification standard: Self-purification time < 20 minutes.

Confirmation method: After 15 minutes of operation, place the particle counter sampling tube under the weighing hood and test the particle concentration in the chamber to determine whether the test results meet the requirements.

See Appendix 11 for the inspection and confirmation results.

Operational Confirmation Deviation Description and Handling Measures:

Operational Confirmation Result Evaluation:

Evaluator:

• Performance Verification

Performance verification can only be conducted after operational verification has been approved.

Cleanliness indicators are tested by the laboratory. Before testing, the clean area to be tested must be disinfected, and the temperature, humidity, and air speed must meet design requirements. The system must be operated according to the weighing hood operating procedures. After the system is operating normally and stabilized, cleanliness indicators will be tested.

Tested Area: Weighing Area.

Monitoring Cycle: Each indicator will be tested once daily for a total of three tests.

2.1 Dust Particle Measurement

Verification Method: According to the dust particle inspection procedures for clean rooms (areas), the sampling points and sample volume are first determined based on the weighing hood area and cleanliness level. The concentrations of 0.5μm and 5μm particles per unit volume of air within the clean environment are then measured. The test results are used to assess the dust particle cleanliness level of the clean area.

The laboratory will issue a report on the test results.

2.2 Airborne Bacteria Determination

Confirmation Method: Based on the cleanroom (area) microbiological inspection procedures, sampling points are determined based on the area of ​​each weighing hood and the cleanliness level. Using the counting concentration method, active microbial particles suspended in the air are collected using an airborne bacteria sampler. The sample is collected 2 cm from the sampling outlet using a 90 mm Ø glass petri dish. The sample is then incubated in an incubator at 30-35°C for 48 hours for colony count. The airborne bacteria concentration per unit volume of air within the clean environment is determined, which is then used to assess the cleanroom’s airborne bacteria compliance.

The laboratory will issue a report on the test results.

2.3 Deposition Bacteria Determination

According to the cleanroom (area) microbiological inspection procedures, sampling points are first determined based on the area of ​​each weighing hood and the cleanliness level. Samples are collected using a 90mm x 15mm glass Petri dish with the mouth open for 4 hours. After completion, the dish is placed in an incubator at 30-35°C and incubated upside down for 48 hours. The number of precipitating bacteria per unit volume within the clean area is then counted and used to assess the compliance of the clean area’s precipitating bacteria.

The laboratory will issue a report on the test results.

Performance Verification Deviation Explanation and Remedy:

Performance Verification Result Evaluation:

Evaluator:

• Verification Conclusion

Analyst:

• Verification Cycle
• Routine testing indicates signs of quality issues in the system, requiring revalidation.
• Revalidation is performed according to the overall validation plan.

• Evaluation and Approval

Verification of Conformity