SOP FOR DYNAMIC PASSBOX

1.0 PURPOSE

To design a Standard Operating Procedure that describes the procedure for operation, and maintenance of Dynamic Passbox.

2.0 SCOPE

This Standard Operating Procedure (SOP) is applicable for the operation, monitoring of performance, and cleaning of Dynamic Passbox for studies conducted at animal house facility (AHF)

3.0 RESPONSIBILITY

3.1 All personnel in the AHF Department shall be responsible for implementation and compliance with the SOP.

3.2 Head/Designees/Study Directors shall be responsible for ensuring the implementation and compliance to the SOP.

4.0 DISTRIBUTION

4.1 The Quality Assurance department is responsible for keeping SOP ‘Master Copy’ approved through the Quality Manager.

5.0 DEFINITION(S) & ABBREVIATION(S)

5.1 Definition(s)

5.1.1 Pass box is used to transfer the material from a lower cleanliness area to a higher cleanliness area or vice-versa in the classified area and is also known as the hatch. The pass box works as a barrier between two cleanliness-level areas.

5.2 Abbreviation(s)

5.2.1 SOP: Standard Operating Procedure

5.2.2 AHF: Animal House Facility  

5.2.3 IPA: Isopropyl alcohol

5.2.4 UV : Ultra Violet

5.2.5 ISO: International Organization of Standardization

5.2.6 HEPA: High-Efficiency Particulate Air

5.2.7 dB: Decibel

6.0 PROCEDURE

6.1 Introduction

Dynamic Pass Box equipment is made of powder-coated high-grade stainless steel (304 / 316 / 316 L) with international quality standard components including mechanically or electrically interlocked doors and UV light. These dynamic pass box equipment are equipped with a suction filter made of stainless steel with 95% down to 5µ efficiency (EU-4rating) and a supply filter made of aluminum with 99.999% down to 0.001 µ (EU-14 Rating.) An interlock guard system controls the inlet and the outlet of PASS BOX not to be opened at the same time, in order to prevent cross-contamination.

Fig 1: Pass Box

6.2 Principle

Dynamic pass box has a system known as an interlock guard which helps to control both the outlet and the inlet so that there is no time that the two are opened. Due to this, dirt and other loose particles are removed from the materials being transferred to the laboratory and vice versa.

6.3 System specification

6.4 Operation

6.4.1 The working area should be cleaned with 70% Isopropyl alcohol.

6.4.2 Main supply should be kept ON.

6.4.3 The motor blower, visible light, and UV light should be switched ON.

6.4.4 After 30 min, record the pressure differential of the Magnehelic gauge in mm of the water column in the pressure differential record of the dynamic pass box.

6.4.5 UV light should be switched off after completion of work and the burning time of UV should be noted in the record.

6.4.6 Working hours of UV light should be checked by auto recorder. Total burning hours should not be greater than 3000 hours.

6.4.7 If working hours are more than 3000, replace the UV light with a new one.

6.4.8 The motor blower and UV light are continuously switched on until the material is there in the pass box except for the media (in case of media switch off UV light).

6.4.9 The UV light of the garment cabinet should be switched off 15 minutes before opening the door of the pass box or before replacing the material.

6.4.10 After replacing the material from the pass box, the door should be closed, and the UV light.

6.4.11 If any drop in pressure differential of the Magnehelic gauge of the dynamic pass box is observed during operation, then inform maintenance personnel for pre-filter cleaning, and the maintenance department maintains records of the same.

6.4.12 Monitoring Performance

6.4.12.1 Prepare the plates of soybean casein digest agar as per the SOP of media preparation for microbial bioburden evaluation.

6.4.12.2 Pre-incubate the plates before exposure at 30 ˚C to 35 ˚C for 24 hours.

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

6.4.12.4 Expose these plates for 30 minutes at rest in five different locations of the garment cabinet.

6.4.12.5 After exposure, plates are incubated at 30 ˚C to 35 ˚C for 48-72 hours to get the number of bacterial colonies & further same plate is incubated at 20 to 25 ˚C for 48-to 72 hours to get fungal count.

6.4.12.6 Keep the negative control plate without exposure and the positive control plate by exposing the plate to the outside environment.

6.4.12.7 Maintain monitoring performance record.

6.4.12.8 Frequency: Performance of dynamic pass box will be performed every fortnight.

6.4.12.9 Acceptance criteria: Less than 1 cfu/plate. Positive control should show growth and negative control should not show any growth.

7.0 PRECAUTIONS

7.1 First it should be making sure that the pass box is well cleaned with 70% IPA and wiped with lint-free cloth.

7.2 UV light and visible light should be kept ON.

7.3 Both the doors of the pass box should not be opened simultaneously.

8.0 REFERENCES & ATTACHMENTS

8.1 Reference

8.1.1 Dynamic pass box service manual

8.2 Format

9.0 REVISION HISTORY

9.1.1 Maintain a record of all SOP revisions, including the version number, date, description of changes, and the names of the individuals who prepared, reviewed, and approved the revision. This record should be kept along with the current version of the SOP.

END OF THE DOCUMENT

You may like to read these links: 

1. List of All SOPs and Documents for the Microbiology Laboratory

2. List of All SOPs and Documents for In-vitro Laboratory

3. List of All SOPs and Documents for the In-vivo Laboratory.

4. List of All SOPs and Documents for Clinical Research

5. List of Instruments and Equipment Used In Laboratory Animal Facility

6. Animal  Facility Design - Small Laboratory Animals (Rat, Mice, Rabbit, Guinea Pig)

7. List of Chemicals Needed for In-vivo Laboratory

8. List of Physiological Data for Small Laboratory Animals 

9. List of All SOPs and Documents for the Animal House Facility

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