TABLE OF CONTENTS
- Approvals
- Revision History
- General
- Description
- Special Features
- Regulatory Requirements
- Utilities
- Documentation
- Inspection and Testing
- Scope of Supply & Supply Features
- Guarantee & Warranty
- Data Sheet/Technical specification sheet
1. Approvals
These specifications shall have been reviewed and approved by the following personnel:
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2. Revision History
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3. General
Brief Description of Project: The project is being implemented for the manufacture of Formulation.
- Name of Client: PharmaGuide Ltd.
- Site Location:
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 the following operations.
- Air Showers shall be self-contained chambers installed at the 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 requirements 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 utility requirement.
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 and testing include the following.
- QA Plan should be submitted by the supplier for approval on placement of Purchase Order.
- Stage-wise inspection may be carried out with a 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 the site
- FAT
- Submission of DQ, IQ, OQ, and PQ Validation document
Supply Features
- Air Shower will be supplied in clean and sealed condition.
- All nozzles of the 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
- The supplier will be responsible for the replacement, at no charge, of all faulty material or defective workmanship for 12 months after installation or 18 months after the supply, whichever is earlier.
- Process Performance guarantee shall be executed by the supplier for performing the system as per Process conditions indicated in the Technical Specs of the Purchase Order.
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 can detect if the person is entering or exiting the controlled environment via door sensors and a time-sequenced control.
B) The System Should consist 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 unlock doors in case personnel open the air shower door but do not actually enter, thus preventing accidental lockouts.
- 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 years excluding consumable parts and accessories.
- An emergency stop button should be mounted on both sides. Should be with negative pressure.
- PLC Controlled based operation.
- Permanently 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.
Tags
Engineering
