- Cleaning of Clean- Room Pass Boxes:
(A) Subject: Procedure for Cleaning of Class- Room Pass Boxes.
(B) Purpose: This procedure is applicable for Cleaning of Clean- Room Pass Boxes used in the formulation plant of pharmaceutical company.
(C) Responsible Persons:
- For the cleaning of equipment- Production Operator/ Technician.
- Surety about the Cleanliness of Equipment- Production Operator/ Executive.
(D) Compliance: Production Head and QA Head are required for the compliance of this cleaning procedure.
- Switch off main power supply of machine.
- Keep the Pass Box Exterior and Interior free from dust:
- Firstly, clean the cabinet; door; door handle; SS Caps and light diffuser by using dry lint free duster.
- Before starting usage for the first time in a day, clean with 70% Isopropyl Alcohol/ Disinfectant using a non- fiber shedding cloth.
- Then, Wipe out Cabinet; door; door handle and hinges by using wet lint free duster.
- Inside cleaning of Clean- Room Pass Boxes is recommended in following cases:
- Before starting any work in the Pass Box.
- In the case of liquid spillage in the pass box or whenever required.
- In the last, Affix “Cleaned” labelled on the Clean- Room Pass Box.
- Shutting- Down Procedure:
- First, disconnect all utilities.
- Then clean the entire area with 70% Isopropyl Alcohol/ Disinfectant.
- Then, Record the details of UV burning, differential pressure.
Note: UV light shall be replace after completion of three years or 8000 burning hours whichever is earlier.
- Expose the plate in the pass box on every working day and record.
- Perform the revalidation of Clean- Room Pass Boxes on yearly basis.
- Master Copy- Quality Assurance.
- Controlled Copies- Quality Control & Assurance and Production.
- Monitoring of Clean- Room Pass Boxes:
- Transfer the pre- incubated soybean casein digest agar Petri- Plate into the Pass Box (LAL test- room to incubator).
- Then, enter the respective pass box clean- room area.
- Decontaminate the external surface of the Petri Plates with the help of sterile mop soaked in a filtered sporicidal agent.
- Mark the Petri Plates at the base with the following details by using marker:
- Media Lot Number
- Name of the location/ ID
- Date of Exposure
- Exposed by
- Place the Petri Plates inside the respective clean- room pass box and remove the upper lid of the Petri Plate and keep it in an inverted position.
- Expose the media plates for 4 hours. After 4 hours of exposure, close the Petri Plate with lid.
- Collect the Petri Plate and then place them into the incubator.
- Incubate the exposed Petri Plate in an incubator in an inverted position at 32.5 ± 2.5 °C for 5 days.
- After incubation observe the plates for a number of colonies on the colony counter or in the light source by using a marker.
- Note down the observation.
- If the counts obtained are above the limits specified below, investigate the results and take necessary actions.
- Frequency of Monitoring: Class A- Daily.
- Acceptance Criteria:
- Action Limit: Class A- 1 CFU/ Plate.
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