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Ss 304 Pharmaceutical Equipment Dynamic Pass Box For Pharmaceutical Industry

The document describes the dynamic pass box, a stainless steel cubicle designed to transfer materials between non-controlled and controlled environments while preventing contamination. It outlines its features, including interlocking doors, HEPA filters, and UV lighting, as well as a Standard Operating Procedure (SOP) for cleaning and operation applicable to various production and quality control areas. Responsibilities for executing and supervising the SOP are defined, along with safety considerations and detailed cleaning and operational procedures.

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ROHIT TRIPATHI
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42 views3 pages

Ss 304 Pharmaceutical Equipment Dynamic Pass Box For Pharmaceutical Industry

The document describes the dynamic pass box, a stainless steel cubicle designed to transfer materials between non-controlled and controlled environments while preventing contamination. It outlines its features, including interlocking doors, HEPA filters, and UV lighting, as well as a Standard Operating Procedure (SOP) for cleaning and operation applicable to various production and quality control areas. Responsibilities for executing and supervising the SOP are defined, along with safety considerations and detailed cleaning and operational procedures.

Uploaded by

ROHIT TRIPATHI
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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A dynamic pass box is a cubicle box which has got interlocked doors located on both sides.

This protects the controlled


environment from being polluted while the transfer of material is taking place inside

Dynamic pass box: Dynamic pass box is mainly installed between non controlled environment to a controlled

environment. We can say it is used to pass materials from non-controlled to a controlled area. the main features of

the dynamic pass box are:


 The Dynamic pass box is made of Stainless steel (SS 304), having a cubical shape.
 The dynamic pass box may be of different kinds like cascade, sink, or bubble.
 It has an interlocking system on both sides to protect from contamination and cross-contamination.
 Dynamic pass box door can open one side at once, and one door will be closed other side.
 It is fitted with a suction filter of around 0.3 microns with a HEPA filter.
 Dynamic pass box also fitted with a pressure Magnehelic gauge ranging from 0 to 25 mm of WC.
 It also contained a motor blower of 1/5 hp to blow out dust particles.
 Dynamic pass box also fitted with a UV light of 18 watts.
 It also has a fluorescent lamp of around 20 watts to produce visible light.

Related Post: SOP on Cleaning and Operation of Dynamic Pass Boxes

SOP on Cleaning and Operation of Dynamic Pass Boxes


1.0 Scop: To Laydown procedure on Cleaning And Operation Of Dynamic Pass Boxes

2.0 Applicable to This SOP is applicable for cleaning and operation dynamic pass boxes (GMP Make) located in

various Production, QC, and warehouse rooms.

3.0 Responsibility:

3.1 Asst. Manager/ Sr. Officer / Officer/Line coordinator shall execute this SOP.

3.2 Manager / Sr. Manager Shall supervise that the process is being followed as per SOP.

3.3 Head-Quality Assurance for ensuring the compliance of this SOP.

4.0 Safety considerations:

4.1 Do not try to open both side doors of the dynamic pass box forcibly at the same time.

4.2 Pressure on the Magnehelic gauge must be within the limit (10 to 15 mm of water).

4.3 70 % IPA shall be used within the specified use period on the label.
5.0 The Equipment:

5.1 (For Material entry from the warehouse)

5.2 (For the Material transfer to the warehouse)

6.0 Materials and reagents:

6.1 Filtered 70% IPA

7.0 Preparation of solutions:

7.1 follow SOP for Isopropyl alcohol 70% Preparation

8.0 Procedure:

8.1 Cleaning procedure:

8.1.1 Before cleaning, switch off the HEPA (High-Efficiency Particulate Air) filter blower.

8.1.2 Clean the pass box with a dry lint-free mop from inside and outside.

8.1.3 Disinfect the pass box with filtered 70 % IPA.

8.1.4 Frequency: Pass box shall be cleaned daily and after use, if required.

8.2 Operation of the Dynamic Pass Box (GMP Technical Solution Make):

8.2.1.1 Check light on the panel which shows the presence of Power supply

8.2.1.2 Press the “HEPA Filter ON” button to switch ON the blower.

8.2.1.3 Check the differential pressure on the gauge. It shall be within 10-15 mm of water.

8.2.1.4 Press the Door Open button on the panel.

8.2.1.5 Open the door and keep the material to be transferred.

8.2.1.6 Close the Door.


8.2.1.7 Press the door open button on the other side of DPB.

8.2.1.7 Open the door, take out the material and close the door again.

8.2.1.8 In case of spillage, clean the inner and outer surface of the equipment with the help of a clean mop soaked

with 70 % IPA.

9.0 Abbreviations:

QA: Quality Assurance

SOP: Standard Operating Procedure

IPA: Isopropyl alcohol

mm: millimeter

DPB: Dynamic Pass Box

% : Percent

PR: Production

Sr.: Senior

HEPA: High-Efficiency Particulate Air

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