ULTRATECH INDIA

LTD

Technical Specification Revision: P0

Air Shower Page 1 of 6

1 Approvals

These specifications shall have been reviewed and approved by the following personnel:

ULTRATECH INDIA LTD

Name Department Signature Date

Prepared by: Mr. RAJESH Projects

Checked by:

Approved by:

2 Revision History

Revision Date Revision Summary

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 TABLE OF CONTENTS

1 Approvals .................................................................................................................................................................................. 1
2 Revision History ...................................................................................................................................................................... 1
3 General ....................................................................................................................................................................................... 3
4 System description .................................................................................................................................................................. 3
5 Special Features ....................................................................................................................................................................... 3
6 Regulatory Requirements ..................................................................................................................................................... 3
7 Utilities ...................................................................................................................................................................................... 3
8 Documentation ........................................................................................................................................................................ 4
9 Inspection and Testing .......................................................................................................................................................... 4
10 Scope of Supply & Supply Features............................................................................
11 Guarantee & Warranty ........................................................................................................................................................... 5
12 Data Sheet/Technical specification sheet ......................................................................................................................... 6

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3 General

Brief Description of Project: The project is being implemented for the manufacture of
Formulation.
 Name of Client: M/s Ultratech
 Site Location: Taloja , Maharashtra, India

4 System description

The system Brief description.

 SS Air shower will be utilized for exit from the clean room.
 Shall be provided with necessary accessories.
 It will be provided Flameproof /NFLP Operating Accessories.

The SS Air shower is required to carry out following operations.

 Air Showers shall be self contained chambers installed at exit to clean rooms and other controlled
environments. Should minimize particulate matter exiting the clean space. Personnel exiting the
controlled environment are “scrubbed “by high velocity HEPA-filtered air jets with velocities of 20-22m/s
(4000-4300fpm).

5 Special Features

 Entirely with cGMP operation.

 SS316 Quality Material

6 Regulatory Requirements

The AIR SHOWER will meet or exceed the requirement of the following:
 Traceability of calibration certificates to National / International standards
 Traceability of all product contact materials
 Certification for Elastomers as per USP Class VI
 FDA’s Current Good Manufacturing Practices (cGMP)
 Hygienic construction as needed for pharmaceutical use in finished formulations.

7 Utilities

Vendor to define on utilities requirement

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8 Documentation

 Technical catalogues.
 Schematic GA drawing along with layout dimensions
 As built Drawing
 Engineering file.
 List of bought out items with makes
 Design Specifications
 Material Test Certificate and all other certificates as required for the Validation protocols.
 Calibration certificates for all instruments
 All testing reports including internal reports
 Pressure test report
 Operation and instruction manuals
 Recommended Spare Parts List

9 Inspection and Testing

Inspection & Testing includes following

 QA Plan should be submitted by supplier for approval on placement of Purchase
Order.
 Stage wise inspection may be carried out with third party.
 Factory Acceptance Test will be done.

The scope of supply will include the following:

 Air Shower - 7 Nos

 All components as in clause 4 & described further in clause 11.
 Documentation as per Clause 8
 Inspection and testing as per Clause 9
 Delivery to site.
 Supervision of Installation and Commissioning at site
 FAT
 Submission of DQ,IQ,OQ,PQ Validation document

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 Supply Features

 Air Shower will be supplied in clean and sealed condition.

 All nozzles of Air Shower will be delivered with all outlets and inlets sealed with
SS blind flanges.
 Air Shower will be packed and sealed in such a way as to prevent damage.

10 Guarantee & Warranty

 Supplier will be responsible for replacement, at no charge, of all faulty material or

defective workmanship for 12 months after installation or 18 months after supply,
whichever is earlier.
 Process Performance guarantee shall be executed by supplier for performing the
system as per Process conditions indicated in Technical Specs of Purchase Order.

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11 Data Sheet/Technical specification sheet

A) GENERAL DESCRIPTION :

Personnel may exit the controlled environment through the air shower. When entering the controlled
environment the shower is activated. When exiting the shower is disabled to reduce throughput time. The
air shower program is able to detect if the person is entering or exiting the controlled environment via
door sensors and a time-sequenced control.

B) System Should consists of the following:

 Air Shower filters should meet the IESTRP- CC001.3 recommended practice for HEPA performance
(USA), and EN 1822 for H14 performance . Recirculation path to be with “BIBO”.

The auto reset feature should unlocks doors in case personnel open the air shower door but do not
actually enter, thus preventing accidental lock-outs.

In case of a power failure, all doors should unlock automatically, and controller settings saved.

All electrical components are UL listed / recognized.

The Air Shower should be warranted for 2 year excluding consumable parts and accessories.

An emergency stop button should be mounted on both side.

Should be with negative pressure.

PLC Controlled based operation

Permenently lubricated blower direct driven centrifugal blower.

Indicator lamps should indicate if doors are Locked or unlocked, thereby regulating The flow of
personnel in and out of the Air shower.

Heavy-duty, durable ss framed Door assemblies are constructed with glass windows permitting
visibility.

The auto reset feature unlocks doors In case personnel open the wet-mist shower Door but do not actually
enter, thus Preventing accidental lock-outs.

Suitable numbers of spray nozzles at appropriate locations to remove the particle settled on PPE.

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