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Standard Operating Procedure (SOP) for Operation, Cleaning, and Qualification of Dynamic Pass Box used in the pharmaceutical manufacturing plant.

Dynamic Pass Box used for the transfer of material from one area to another in isolation by means of mechanical/electromagnetic door interlocking process that ensures opening of only one door at a time.

This process helps in avoiding cross-contamination between two areas.

SOP for Dynamic Pass Box

1.0   PURPOSE:

• • To lay down the procedure for operation, cleaning, and qualification of Dynamic Pass Box.

2.0   SCOPE:

• • This Standard Operating Procedure is applicable for the handling of dynamic pass box installed at the Microbiology Department.

3.0   REFERENCES:

• • The user manual of Dynamic Pass Box.

4.0   RESPONSIBILITY:

• • Officer or Executive of the Microbiology department shall be responsible for the preparation of new or revision of existing SOP.

• • Head of the department/designee of respective areas & QA shall be responsible for reviewing the SOPs.

• • Site Quality Head and Head QA shall be responsible for the approval of SOP.

5.0   ABBREVIATIONS USED IN SOP FOR DYNAMIC PASS BOX:

• • % :  Percentage

• • °C: Degree Celsius

• • CC: Change Control (SOP for Change Control Management)

• • CCR: Change Control Record

• • DPB:  Dynamic Pass box

• • IPA:  Isopropyl alcohol

• • UV:  Ultra Violet (SOP for UV Cabinet)

 6.0   PROCEDURE FOR HANDLING OF DYNAMIC PASS BOX:

• Precautions during handling of dynamic pass box:

• • Ensure that the UV light shall not glow while opening the door.

• • Ensure that the pass box doors closed properly.

• • Do not open the doors on both sides at the same time to avoid contamination.

• Cleaning of Dynamic Pass Box:

• • Open the pass box door by pushing the Press Release

• • Clean the inner sides as well as the outer side of Pass Box with clean & lint-free cloth.

• • Sanitize its inner surface using 70 % IPA.

• • Sanitize the outer surface of Pass Box using 70 % IPA and close the door.

• • Fill the cleaning status as per Annexure-1 and a respective logbooks.

• • Cleaning frequency: Daily morning and whenever required.

• Operation of Dynamic Pass Box:

• • Switch on the main Power Supply.

• • After Power Supply the motor blower shall start automatically.

• • After 30 Minutes record the Pressure differential of Magnehelic gauge in mm of the water column in the pressure differential record of dynamic pass box as per Annexure-2.

• • Switch “ON” the UV light and let it in operation for 30 minutes.

• • After 30 minutes switch OFF the UV light and enter the burning hour details of UV as per Annexure-2

• • Check the burning hours of UV light by its auto recorder.

• • Total burning hours should not be greater than 1000 Hours.

• • If the working hours are more than 1000 hrs. replace the UV light by the new one.

• • Open of the pass box door by pushing the Press Release Switch.

• • Place the required materials.

• • Motor blower is continuously switched on until the material is there in the pass box.

• • After replacing the material from the pass box close the door of the pass box.

• • If any drop in pressure differential of the Magnehelic gauge of dynamic pass box is observed during operation,

• • Then inform maintenance personnel for pre-filter cleaning and enter the details in Annexure-2.

• Monitoring Performance of Dynamic Pass Box:

• • Prepare the Plates of Soyabean casein digest Agar with glycerol (if required) as per respective SOP.

• • Pre incubate the plates before exposure at 30°C to 35°C for 24 Hours.

• • Ensure that the dynamic pass box is ON for a minimum of 30 minutes before exposing the plates.

• • Expose these plates for 4 hours on two locations for Passive air sampling & one location for Active air sampling (1000 L Air) of the dynamic pass box.

• • After exposure, plates are incubated at 30-35°C for 48-72 hours to get the no. of bacterial colonies & further the same plate incubate at 20-25°C for 48-72 hours to get the fungal count.

• • Enter the result of total viable counts in Annexure-3.

• • Keep one negative control plate without exposure.

• • Limit: Active Air sampling: NMT 200 CFU/m³        Passive Air sampling: NMT 100 CFU/Plate

• • Frequency: Weekly
• Qualification of Dynamic Pass box
  • Frequency: Once in six months ±15 days.
  • The qualification of DPB required:

• • If any failure observed during routine monitoring.

• • In case of breakdown, maintenance, preventive maintenance.

• • In case of a change in the installation location.

• • As per schedule

• Operational tests of Dynamic Passbox Qualification:

• • The following tests are performed during qualification and results are within acceptance criteria.

• • • PAO/DOP testing (integrity testing) of the HEPA filter.

• • • Particle count test

• • • Air velocity test.

• • PAO/DOP Test ( filter integrity testing):

• • Feed the PAO (Poly Alfa Olefin)/DOP Aerosol at the suction of blower.

• • Measure the upstream concentration of PAO/DOP as a 100% concentration.

• • Do the scanning after HEPA filter.

• • Acceptance criteria: The penetration level should be less than 0.01%.

• • Particle count test:

• • Ensure that particle count of the work station is done by using a calibrated airborne particulate matter counter.

• • Ensure that the sampling station is cleaned.

• • Run the blower at least 1 hour before taking the particle count.

• • Take the samples at 5 different locations.

• • Acceptance criteria: Particle count of size 0.5 micron and large should not be more than 100 particles per cubic feet & 5 micron and large should not be more than 0 particles per cubic feet

• • Air Velocity Test:

• • Start the pass box.

• • Take the air velocity by calibrated anemometer 6” away from the grill at five different locations in ft./min.

• • Acceptance criteria: Average air velocity should 90±20 ft./min.

• • Qualification shall be done by the external agency if the facility not available at the location.

• • After Completion of Qualification writes the details and pest as per Annexure-3.

7.0   ANNEXURES:

Annexure-1: Cleaning Status Label

Annexure-2: Operation Record of Dynamic Pass box 

Annexure-3: Report of Total Microbial Count of Dynamic Pass box

Observations

Remarks:

Microbiologist:                                                                                               Reviewed By:

(Sign./Date)    :                                                                                                (Sign./Date)  :

Annexure-4: Qualification Status Label