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Fabtech - Isolator
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   Product Description

Salient Features

- Access-Transfer Dances (Input Output devices) Selection criteria : Application and OEL
- Option available : Continuous linear port Pass boxes with or without controlled air flow with interlocked doors. Rapid transfer ports etc
- Air-Handling system &Gas system (Aa Management) Selection criteria: Materials used -Volumes. processed. Basic design of isolator. terility assurance required etc
- This is a key design feature, a close interaction between user and Fabtech is required to arrive at just right air handling system and controls.
- Controls and Instrumentation
- Selection criteria Users requirement specification based on process control
- Option available : various degree of control and instrumentations available from simple interlock to software controlled operation.
- Exhaust Treatment
- Selection criteria User's requirement specification based on application.
- Option available: Based on materials and volume exhaust, treatment could change from just filtration to filtration. scrubbing and incineration if required.
- Sterilization / Decontamination
- Selection criteria User requirement specifications taking in account entire process.
- Option available. Hydrogen peroxide, Ethyl oxide. Per acetic acid.
- Chlorine-dioxide are some of the agents vodely used In each of these, a complete understanding of lethality of the agent. the generation system and validation are of greatest importance for successful
   sterilization and decontamination process.
- Fabtech possesses capability to design, supply and validate tailor made isolation devices complying to above parameters.
- Key components like filters. blowers, RTP(RAPID TRANSFER PORT). Gloves etc. imported from EU. details provided on request


- We provide
- DO /10100 documentation
- ( FAT and support of the PO)
- Raw material certifications
- In-process test certifications
- Instrument calibrations
- User manual
- Others documentation are optional
- The detailed supply would be comprehensive of one hard copy of the following documentation, in English language
- Layout drawing
- P&I Diagram
- Wiring diagrams
- Use and Maintenance Manual
- Material certificates
- HEPA filters efficiency certificates
- Installed components data sheets
- Manufacturer instrument calibration certificate
- FAT procedure and results

The following activities will be considered during FAT:

- Dimensional verification
- P 5 I Diagram verification
- Components check
- Leak test
- Documents verification
- Functional check
- Alarm check
- Spare parts list Related

Standard and Regulation

- FDA 2004 -Sterile Drug Products Produced by Aseptic Processing
- EU GMP 2008 Guideline for Medicinal Products, Annex 1
- PIC/S 014-2 Isolators Used for Aseptic Processing and Sterility Testing
- ISO 14644-7: Cleanrooms and Associated Controlled Environments - Separative Devices
- ISO 13408-6 Aseptic Processing of Health care Product-Part6: Isolator systems
- American Glovebox society guideline AGS-GOOI - 2007
- ISO 10648-2: Classification according to leak tightness and associated checking method


- Validation of isolator includes the following
- HEPA filter integrity testing
- Velocity profile
- Airborne particulate count
- Light intensity
- Sound level
- Vibration level
- Leak testing
- PLC logic and interlocking
- Biological validation in case of sterile isolator

Validation equipment

- Particle counter
- Aerosol photometer and generator
- Relative humidity/air temperatur; velocity
- measuring instrument
- Micro manometer
- Vapour Hydrogen Per-oxide system
- Gas Detection Instrument
- Thermal anemometer

   Fabtech Technologies International Ltd.   
Contact Person: Mr. Asif Khan
Address: 717, Janaki Center, Off. Veera Desai Road
Area: Andheri (West)
Pin Code: 400053
City: Mumbai
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