DQ of Sampling Booth (RLAF) Design Qualification

OBJECTIVE for DQ of Sampling Booth

To determine that the DQ of Sampling Booth (RLAF) Design Qualification 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

Description

Objective

Table of contents

Scope

Pre-Approval of Documents

Responsibility (client and manufacturer)

Scope of supply

Brief process description

Technical specifications

Safety features and alarms

Technical specifications of the bought out components

Post approval of Documents

List of Abbreviations

SCOPE

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

This document is applicable for Sampling Booth (Reverse Laminar Air flow).

PRE APPROVAL OF DOCUMENTS for DQ of Sampling Booth

Prepared by

Designation	Name	Date	Signature
Executive/Officer QA

Reviewed By

Designation	Name	Date	Signature
Head Engineering
Head Production
Head Warehouse
Head Quality Control

Approved by

Designation	Name	Date	Signature
Head QA

RESPONSIBILITY (Client and Manufacturer) :

Client:

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 Sampling Booth (Reverse Laminar Air flow).

To provide the technical Specifications of the Sampling Booth (Reverse Laminar Air flow).

To provide the information on bought out components.

BRIEF PROCESS DESCRIPTION

Reverse Laminar Air Flow (RLAF) is a specialized air handling system used in the pharmaceutical industry to maintain a controlled and contaminant-free environment. By directing airflow from a contaminated area towards a clean area, RLAF prevents the introduction of contaminants into critical zones, ensuring the safety and quality of pharmaceutical products. Reverse Laminar Air Flow (RLAF), or Reverse Laminar Flow (RLAF), is a specialized air handling system used in pharmaceutical and clean room environments. It is designed to maintain a controlled environment by preventing the contamination of sensitive products, equipment, or processes.

Unlike traditional laminar airflow systems, where the air flows from a clean area toward a contaminated area, RLAF operates in the opposite direction. The air flows from a contaminated area towards a clean area, minimizing the risk of contaminant introduction

The working principle of Reverse Laminar Air Flow (RLAF) involves the controlled direction of airflow from a contaminated area towards a clean area, ensuring that contaminants are contained and prevented from reaching critical zones. Here’s a breakdown of the working principle:

Airflow Direction: In RLAF, the airflow is reversed compared to traditional laminar flow systems. Instead of flowing from a clean area toward a contaminated area, the air is directed from a contaminated area toward a clean area.
Contaminated Area: The contaminated area refers to the region where potentially harmful substances, particles, or processes are present. This can include areas with active pharmaceutical ingredient (API) handling, equipment cleaning, or other processes that generate contaminants.

Clean Area: The clean area is the designated zone where sensitive pharmaceutical products, equipment, or processes requiring a controlled environment are located. It could be an aseptic filling line, sterile compounding area, or any other critical zone.

Airflow Pattern: RLAF creates a controlled airflow pattern that effectively prevents contaminants from entering the clean area. The airflow is typically generated by ventilation systems, air handlers, and HEPA (High-Efficiency Particulate Air) filters.

Containment and Exhaust: The RLAF system ensures that the contaminated air is contained within the contaminated area and exhausts safely. This prevents the spread of contaminants to the clean area and maintains the required cleanliness levels.

Air Filtration: RLAF systems incorporate HEPA filters that effectively capture and remove airborne particles and microorganisms. These filters have high efficiency in removing particulate matter, typically with an efficiency of 99.97% for particles as small as 0.3 micrometers.

Validation and Monitoring: Regular validation and monitoring of the RLAF system are crucial to ensuring its effectiveness. Airflow velocity measurements, particle counts, and microbial sampling are performed to verify that the system is operating within specified parameters and meeting regulatory standards.

The basic construction of the machine consists of :
Standard stainless steel 304 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 RLAF consists of the outer casing and the inner chamber.

UV Light

UV light are designed inside RLAF for disinfection of material.

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 RLAF, dilutes and filters the air inside.

Electrical chamber and mechanical chamber:

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

TECHNICAL SPECIFICATION for DQ of Sampling Booth:

Sr. No.	Particulars	Specification
1	Make	As per Requirement
2	Model	GMP
BODY
1	Overall size	1330x1565x 2130mm
2	Internal Size	1220x915x1830mm
3	Cabinet MOC	SS 304
4	PAO Port	SS 304
MAGNEHELIC GAUGE
1	Make	As per Requirement
2	Qty	1 Nos
3	Range	0-50 mmwc
MAGNEHELIC GAUGE
1	Make	As per Requirement
2	Qty	1 Nos
3	Range	0-25 mm wc
Mini Pleat HEPA Filter
1	Make	As per Requirement
2	Type & Size	Box Type &1220x 610x 69mm
3	Efficiency	99.997% @ 0.3 Micron
4	Rated Capacity	750 CFM
5	Media	Fiber Glass
6	Frame	Aluminum
7	Qty.	01 Nos
Pre -Filter
1	Make	As per Requirement
2	Type & Size	Flange Type &790x 560 x 50 mm
3	Efficiency	90% down to 10Micron
4	Frame	Aluminum
5	QTY.	02 Nos.
Mini Pleat HEPA Filter
1	Make	As per Requirement
2	Type & Size	Box Type & 610x 305x 69mm
3	Efficiency	99.997% @ 0.3 Micron
4	Rated Capacity	480 CFM
5	Media	Fiber Glass
6	Frame	Aluminum
7	Qty.	02 Nos
Blower Motor Drive Unit
1	Make	As per Requirement
2	Hp/rpm	1/2 1350 rpm
3	Watt/Phase	230 Watt, 1 Phase
4	Qty.	02 No.
Suction Grill
1	Make	As per Requirement
2	Type	Capsule Type Perforated
LED Light
1	Make	As per Requirement
2	Size	4 Feet
3	Watt	20w
4	Qty.	1 Nos
Switch
1	Make	As per Requirement
2	Watt	10 AMP.
3	Qty.	3 Nos.
4	Power Supply	Single Phase 230 Volt
5	Type	On-Off
MCB
1	Make	As per Requirement
2	Watt	16 AMP
3	Qty.	1 Nos
UV Light
1	Make	As per Requirement
2	Size	1 Feet
3	Watt	8w
4	Qty.	1 Nos
Hour Meter
1	Make	As per Requirement
2	Qty.	1 Nos

SAFETY FEATURE & ALARM

Safety feature	Function
Electrical Insulation	Safety
Earthing	To avoid the shock

TECHNICAL SPECIFICATION OF THE BOUGHT OUT COMPONENT

A) Instruments Requiring Calibration

Sr. No.	Instrument	Location	Make	SR. NO.
1	Magnehelic gauge	Sampling Booth
2	Magnehelic gauge	Sampling Booth

B) Equipment structure:

Sr. No	Description	Specified	Location
1	Make.		Sampling Booth
2	Serial No.		Sampling Booth

POST APPROVAL OF DOCUMENTS