DQ of Dynamic Pass Box (Design Qualification)

OBJECTIVE for DQ of Dynamic Pass Box

To determine that the DQ of Dynamic Pass Box perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that Design consistently meets per-determined specifications under normal condition, and where appropriate the worst case situations.

Table of Content for DQ of Dynamic Pass Box

Description

Objective

Table of contents

Scope

Pre-Approval of Documents

Responsibility

Scope of supply

Brief process description

Technical specifications

Safety features and alarms

Technical specifications

Post approval of Documents

List of Abbreviations

SCOPE for DQ of Dynamic Pass Box

The scope of this qualification document is to perform the Design qualification to verify the installed components as described in DQ.

PRE APPROVAL OF DOCUMENTS

Prepared by

Designation	Name	Date	Signature
Executive/Officer Engineering

Reviewed By

Designation	Name	Date	Signature
Head Engineering
Head Production

Approved by

Designation	Name	Date	Signature
Head QA

RESPONSIBILITY:

Customer:

To provide the Scope of supply.

To give final approval to drawing and technical data sheet.

Manufacturer:

To design, engineer and provide complete technical details of the Equipment.

To confirm safe delivery of the equipment to the user site.

To ensure that no un-authorized and/or unrecorded design modifications shall take place. If at any point of time, any change is desired by mutually agreed design, change control procedure shall be followed and documented.

SCOPE OF SUPPLY:

Design of the machine shall meet the Scope of Supply finalized with the Customer.
To define the customer’s & the manufacturer’s responsibilities.
To provide the brief process description of Dynamic Pass Box.
To provide the technical Specifications of the Dynamic Pass Box.
To provide the information on bought out components.

BRIEF PROCESS DESCRIPTION for DQ of Dynamic Pass Box:

Dynamic pass box is normally used to transfer materials and goods between clean rooms of different levels or between clean room and non-clean room. Besides UV light and an interlock system, dynamic pass box is equipped with a suction HEPA filter. A dynamic pass box works like an airlock or laminar 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 the other side door remains closed.
Dynamic pass box is a self cleaning pass box. The air sucked by a centrifugal blower than passed through HEPA filter. After the pressure is equalized, the filtered air enters the working zone at a uniform air velocity, forming a clean working environment
When the material is put inside pass box & the door is closed, UV light will turn on and material is placed under UV for some time to kill bacteria. Then the material can be taken out.
The basic construction of the machine consists of :
Standard stainless steel 316 L for contact parts
Non contact parts SS304 with matt finish
Non metallic contact parts, any material with food grade quality having no potential impact on the products

Body:

The body of the box consists of the outer casing and the inner chamber.

Doors:

Two doors (one on each side) with tempered glass windows sealed by durable feather edge rubber prevent airborne particles contamination. Besides, each door has door handle. The door handles are different according to the types of interlock system.

Interlock system:

This is an important of every pass box, ensuring two doors don’t open at the same time. This prevent the risk of cross contamination in clean rooms

UV Light

UV light are designed inside pass box for disinfection of transferred objects before entering the clean room

Fan

It sucks the air and blows it through HEPA filter. The clean air will go into the chamber to sterilize the objects

Filters

Filters are used to remove the airborne particles

Differential pressure gauge

To check the differential pressure across hepa filters

Blower and fan

Clean air enters the inner space of pass box, dilutes and filters the air inside.

Electrical chamber and mechanical chamber:

All mechanical components such as gears, motors, and moving belts, as well as electrical components such as wiring, switches, and MCBs, are installed in this segment.

TECHNICAL SPECIFICATION for DQ of Dynamic Pass Box:

Particulars	Specification
Machine weight	As per Requirement
Capacity	1 HP (0.7 kW)
Model/Type	As per cGMP model
Overall dimension (mm)	As per Requirement
Working dimension (mm)	As per Requirement
Pass box type	3 way opening
General components	Main cabinet Pre Filter (5 micron) with protection grill HEPA Filter ( 0.3 micron) with protection grill Blower and motor assembly Magnahelic gauge for HEPA Filter pressure DOP PortDoor release button Electromagnetic interlocking Power supply plug On/off Switch LED Tube light UV Light Hour meter Switch Socket Light indicators
Air system	Motor blower with suspension
Doors	3 side Door with Glass Window – SS Handles and SS Hinges
Interlock	Electronic interlock system
Alarm system	Preferably the sound alarm/beep shall be provided along with light indication
Motor	Totally enclosed Fan cooled induction flame proof motor
Filters	Mini pleat HEPA Filter Eff. 99.997% (0.3 μ) EU – 14 Grade Pre filter Eff. 95 % (5 μ) EU-5 Grade
Power failure /recovery	In the event of power failure the system shall protect product against damage. The system will stop in a safe mode automatically upon loose of electricity, air & other major utility and will require operator intervention to restart.
Identification	Details of Make, Name, Serial. No., Capacity, Model and Year of manufacture should be available
Utility Requirement	230 V ac, 1 Ph. 50/60Hz.

SAFETY FEATURE & ALARM

Safety feature	Function	Identified by/Date
Electrical Insulation	Safety
Earthing	To avoid the shock

TECHNICAL SPECIFICATION

Equipment structure:

Description	Specified	Method of verification	Actual	Checked by
Make/Model
Specification

Instruments Requiring Calibration

Instrument	Location	Model no.	SR. NO.	Yes/No

POST APPROVAL OF DOCUMENTS for DQ of Dynamic Pass Box