1.0 PURPOSE
To design a Standard Operating Procedure that describes the procedure for operation and maintenance of static Pass box.
2.0 SCOPE
This Standard Operating Procedure (SOP) is applicable for the operation, and maintenance of the Static Pass box.
3.0 RESPONSIBILITY
3.1 All personnel in the Microbiology and Pharmacology Department shall be responsible for implementation and compliance with the SOP.
3.2 Head/Designees/Scientists/Study Directors of the Microbiology, and Pharmacology department shall ensure the implementation and compliance with the SOP.
4.0 DISTRIBUTION
4.1 The Quality Assurance department is responsible for keeping SOP ‘Master Copy’ approved by the Quality Assurance Head.
4.2 The copy of the ‘Control Copy’ of SOP is being distributed in the Microbiology and AHF department and placed near related Equipment/Instruments as Display Copy.
5.0 DEFINITION(S)
5.1 Definition(s)
5.1.1 Pass box is used to transfer the material from the lower cleanliness area to the higher cleanliness area or vice-versa in the classified area and also known as the hatch. Pass box works as a barrier between two cleanliness level areas.
6.0 ABBREVIATION(S)
6.2 Abbreviation(s)
6.2.1 SOP : Standard Operating Procedure
6.2.2 AHF : Laboratory Animal Facility
6.2.4 IPA : Isopropyl alcohol
6.2.5 UV : Ultra Violet
6.2.6 ISO : International Organization for Standardization
7.0 PROCEDURE
7.1 Introduction
7.1.1 Static pass boxes are simple boxes mounted between two areas and are also known as passive pass boxes. The area has a higher cleanliness level and shall have a higher pressure that helps to prevent the entrance of contamination in the sterile area.
7.1.2 Ultra-violet light is also installed in the pass boxes to remove the contamination that may enter during the transfer of material. It should be replaced after 1000 burning hours. Pass boxes should be cleaned with disinfectants at regular intervals.
7.1.3 The efficiency of the pass boxes should be verified by validation. Validation may be done by exposing the known population of the bacterial culture.
7.2 Principle
7.3 System specification
7.4 Operation
7.4.1 Main supply should be kept ON.
7.4.2 It should be ensured that the equipment is in a clean state.
7.4.3 Working area should be cleaned with 70% Isopropyl alcohol.
7.4.4 The Door should be closed and switch on the UV light for 15 min before routine use.
7.4.5 Burning hours should be recorded as shown in the hour's meter of the pass box and switch and switch off the UV light.
7.4.6 Burning hours of the UV light should be maintained once in a day as per format.
7.4.7 Ensure that one door should be closed while transferring the material.
7.4.8 After material transfer, the door should be closed.
7.4.9 Transfer material is to be removed from the opposite side of the pass box.
7.4.10 All the material from the pass box should be removed carefully and then close the door.
7.4.11 UV light shall be replaced after completion of three years or 8000 burning hours whichever is earlier.
7.5 Maintenance
7.5.1 The interior and exterior of the pass box should be free from dust.
7.5.2 Before starting usage for the first time in a day, the pass box should be cleaned with 70 % IPA using a lint-free cloth soaked.
7.5.3 Inside cleaning of the pass box is recommended in the following cases:
7.5.3.1 Before starting any work in the pass box.
7.5.3.2 In the event of liquid spoilage in the pass box or when required.
8.0 PRECAUTIONS
8.1 First it should make sure that the pass box is well cleaned.
8.2 UV light should be kept ON for 15 min before transferring of material.
8.3 Both the doors of the pass box should not be opened simultaneously.
9.0 REFERENCES
9.1 Reference
6.2 Abbreviation(s)
6.2.1 SOP : Standard Operating Procedure
6.2.2 AHF : Laboratory Animal Facility
6.2.4 IPA : Isopropyl alcohol
6.2.5 UV : Ultra Violet
6.2.6 ISO : International Organization for Standardization
7.0 PROCEDURE
7.1 Introduction
7.1.1 Static pass boxes are simple boxes mounted between two areas and are also known as passive pass boxes. The area has a higher cleanliness level and shall have a higher pressure that helps to prevent the entrance of contamination in the sterile area.
7.1.2 Ultra-violet light is also installed in the pass boxes to remove the contamination that may enter during the transfer of material. It should be replaced after 1000 burning hours. Pass boxes should be cleaned with disinfectants at regular intervals.
7.1.3 The efficiency of the pass boxes should be verified by validation. Validation may be done by exposing the known population of the bacterial culture.
Fig 1: Pass Box Setup
7.2 Principle
Static pass box equipment, fabricated with powder coated 304 / 316 grades stainless steel and high-quality components, can eradicate pollutants entirely from the air. These static pass boxes are installed to filter the incoming air in order to keep the air free from dust and other contaminants. With UV light along with an hour-meter, Fluorescent light, buzzer indicator to know the material is kept inside and indicating lamp, these static pass boxes provide excellent working performance in the clean room unit.
|
Product |
: |
Static Pass Box |
|
Construction |
: |
Stainless steel 304/316/316L |
|
Door |
: |
Solid door with mechanical or electrical interlocked |
|
Window |
: |
Tempered glass |
|
Accessories |
: |
Hour meter |
|
Electricals |
: |
Hour meter, UV light, fluorescent light, electromagnet for door
interlocking, buzzer and indicator lamps |
|
Filtration efficiency |
: |
≥ 99.99% @ ≥ 0.3 μm |
|
Power Supply |
: |
220/230 Volts |
|
Certification |
: |
CE and ISO |
7.4 Operation
7.4.1 Main supply should be kept ON.
7.4.2 It should be ensured that the equipment is in a clean state.
7.4.3 Working area should be cleaned with 70% Isopropyl alcohol.
7.4.4 The Door should be closed and switch on the UV light for 15 min before routine use.
7.4.5 Burning hours should be recorded as shown in the hour's meter of the pass box and switch and switch off the UV light.
7.4.6 Burning hours of the UV light should be maintained once in a day as per format.
7.4.7 Ensure that one door should be closed while transferring the material.
7.4.8 After material transfer, the door should be closed.
7.4.9 Transfer material is to be removed from the opposite side of the pass box.
7.4.10 All the material from the pass box should be removed carefully and then close the door.
7.4.11 UV light shall be replaced after completion of three years or 8000 burning hours whichever is earlier.
7.5 Maintenance
7.5.1 The interior and exterior of the pass box should be free from dust.
7.5.2 Before starting usage for the first time in a day, the pass box should be cleaned with 70 % IPA using a lint-free cloth soaked.
7.5.3 Inside cleaning of the pass box is recommended in the following cases:
7.5.3.1 Before starting any work in the pass box.
7.5.3.2 In the event of liquid spoilage in the pass box or when required.
8.0 PRECAUTIONS
8.1 First it should make sure that the pass box is well cleaned.
8.2 UV light should be kept ON for 15 min before transferring of material.
8.3 Both the doors of the pass box should not be opened simultaneously.
9.0 REFERENCES
9.1 Reference
END OF DOCUMENTS
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