Design & Customisation
- URS (User Requirement Specification) - Client specific design and product configuration (DQ - Design Qualification)
- 3D CAD model develop and client exchange and PAT (Process Analytical Technology)
- Equipment modularisation - future-proofing your operations with incremental 'bolt-on' modules as your business needs develop.
Ergonomic Trials & Operator Engagement
- Life-size wooden/proto-type barrier isolator development
- Operator ergonomic testing for sustainable operation and comfort. Also tests to ensure all isolator areas are cleanable (CIP/SIP)
- Full client engagement and design specification (DQ) sign-off before manufacture commences
Factory Validation Testing
- FAT / IQ testing - The partial commissioning & qualification of equipment and/or systems prior to their shipment from our facility
- Hard and soft copies of documentation packs
- 21 CRF 211 - cGAMP and cGMP reviews and auditing
Installation & Commissioning
- SAT / OQ testing - Inspection and/or dynamic testing of the systems at the manufacturing site to qualify the equipment to the DQ / URS
- Provision of skilled and experienced technical engineers and quality assurance personal to conduct PQ (Performance Qualification)
- Development of Standard Operating Procedures (SOPs) with the engagement of the client and their needs
- Client/Operator on-site and off-site training (theory and practical)
- After sales and Asset Healthcare Management options including MQ (Maintenance Qualification)
Isolator Overhaul
- Complete overhauling of in-field isolators (Schematic designs and other manufacturer designs)
- Change Isolator worn parts and procure all necessary new parts/spares
- Full Health testing: Leak test, light and lux test, air changes test, laminar air flow test, noise & vibration test and occupational exposure limit test.
- Recommissioning of the equipment
The value added isolator products we offer include
API Isolators
- Isolators for Sampling and Dispensing
- Isolators for QC
- Isolators for Reactor Charging
- Isolators for ANFD
- Isolators for Centrifuge
- Isolators for PNF & VTD
- Isolators for Milling and Sieving
- Isolators for Micronisation
- Isolators for Weighing and Packing
Formulation Isolators
- Isolators for Dispensing and Sieving
- Isolators for Granulation Line
- Isolators for Tablet Compression Line
- Isolators for Capsule Filling Line
- Isolators for IPQC
- Isolators for Blister Packing
- Isolator for Bottle Filling
Injectable Isolators
- Sterile Isolators for Dispensing, milling and sieving
- Isolators for Compounding
- Sterile Isolators for Filtration
- Sterile Isolators for Liquid Filling Line
- Sterile Isolators for Lypholisation
- Sterile Isolators for Powder Filling Line
- Isolators for External Decontamination
- Sterility Testing Isolators
