Performance Validation Protocol for UV Light Efficiency

Ultraviolet light is extensively employed as an efficient technique for germ control in the pharmaceutical industry. A number of variables, such as lamp strength, exposure duration, distance, ambient conditions, and the type of target microorganisms, affect how effective UV light systems are. Validating the UV system's performance under certain operating conditions is crucial to guaranteeing that it continuously provides the desired amount of disinfection.

The methodology, acceptance standards, and roles for confirming the efficacy of UV light installations used for environmental disinfection within the establishment are described in this Performance Validation Protocol for UV Light Efficiency. Establishing recorded proof that the UV light system functions dependably and accomplishes the necessary microbial reduction in accordance with specified specifications is the goal of the procedure.

To verify that the UV light system maintains constant efficacy over the course of its operating lifecycle, the validation will include performance testing, data collecting, and evaluation. The system will be qualified for regular usage as part of the facility's contamination control strategy in accordance with Good Manufacturing Practice (GMP) criteria if this process is successfully completed.

TABLE OF CONTENT

1. Objective
2. Scope
3. Site of Study
4. Responsibilities
5. Validation Procedure
6. Acceptance Criteria
7. Evaluation of Results
8. Report and Conclusion
9. Abbreviations
10. Annexures

1. Objective

The main objective of this protocol is to evaluate the efficiency of the UV light installed in the Dynamic Pass Box during the transfer of materials into the critical area. The study aims to verify that the UV light provides adequate microbial control to prevent contamination during material transfer operations.

2. Scope

This protocol applies to the validation of UV light efficiency during material transfer through the Dynamic Pass Box located in the Sterile Block at PharmaGuide Laboratories Private Limited. The validation ensures that the UV light effectively reduces microbial load on the surfaces of materials prior to entry into the aseptic area.

3. Site of Study

The Dynamic Pass Box, equipped with a UV light, is installed in the Cleaning and Sterilization Room of the Sterile Production Block. The sterilization area is designed in accordance with Grade C (Class 10,000) cleanliness specifications.

The equipment is positioned for easy access to routine operation, monitoring, and maintenance activities. The Dynamic Pass Box consists of two doors—one opening into the controlled area and the other into the aseptic area—to facilitate unidirectional material transfer while maintaining environmental segregation.

4. Responsibilities

Quality Assurance (QA):

• Review and approve the validation protocol and report.
• Ensure compliance with GMP requirements during execution.

Production Department:

• Coordinate and execute the validation activity as per the approved protocol.
• Ensure proper operation and cleaning of the Dynamic Pass Box before validation.

Engineering Department:

• Verify equipment calibration, maintenance, and UV lamp integrity prior to validation.
• Support in troubleshooting and technical documentation.

Microbiology Department:

• Conduct and record microbial efficiency testing.
• Analyze and interpret microbiological results to confirm UV efficiency.

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5. Validation Procedure

• The Dynamic Pass Box shall be cleaned using lint-free mops and a suitable disinfectant before placing the articles inside.
• The articles to be transferred shall be sanitized using a validated disinfectant and allowed to remain in contact for a minimum of 5 minutes. Avoid handling or contacting the articles during this period.
• After the contact period, the sanitized articles shall be placed inside the Dynamic Pass Box.
• The Dynamic Pass Box is equipped with a UV light source. The articles shall be exposed to UV light for 30 minutes to allow for microbial decontamination.
• Surface monitoring samples shall be collected at intervals of every 5 minutes during the 30-minute exposure period. Sampling shall be performed by a trained microbiologist using appropriate microbiological methods.

6. Acceptance Criteria

The UV light shall be considered effective if a significant reduction or absence of microbial growth is observed on the surface samples collected during the exposure period, demonstrating that the UV light achieves the intended level of microbial control.

7. Evaluation of Results

Upon completion of the validation activity, the microbial test results shall be reviewed and evaluated against the acceptance criteria. Any deviations or non-conformances shall be investigated and documented as per standard procedures.

8. Report and Conclusion

After completion of the validation, a comprehensive summary report shall be prepared, reviewed, and approved by the respective departments. The report shall include all data, observations, and conclusions confirming whether the UV light system meets the established performance criteria.

9. Abbreviations

SP : Standard Protocol

UV : Ultraviolet

SPR : Sterile Production

QA : Quality Assurance

MICRO : Microbiology

DPB : Dynamic Pass Box

SBR : Sterile Block Room

10. Annexure

Annexure No.	Title / Description	Purpose / Remarks
Annexure I	Equipment Details and Identification	Includes make, model, serial number, and location of the Dynamic Pass Box
Annexure II	Calibration and Maintenance Record of UV Light	Provides details of calibration status, lamp life, and maintenance schedule.
Annexure III	Environmental Condition Record	Records temperature, relative humidity, and area classification during validation.
Annexure IV	Sampling Plan and Locations	Identifies sampling points on materials or surfaces inside the pass box.
Annexure V	Microbiological Test Record Sheet	Used for recording microbial counts at different exposure intervals (0, 5, 10, 15, 20, 25, 30 minutes).
Annexure VI	Result Summary Sheet	Summarises test results, microbial count reduction, and final evaluation.
Annexure VII	Deviation / Observation Report (if applicable)	Used to record any deviations or non-conformances during validation.
Annexure VIII	Photographic Evidence / Layout Diagram	Includes images or diagrams of the Dynamic Pass Box setup and sampling points.

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