Design & Customisation
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
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
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
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 training and Asset Healthcare Management options including MQ (Maintenance Qualification)
Isolator Overhaul
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
Asset Healthcare Management
Asset Healthcare Management
Standard Group also provide an Asset Healthcare Management service, designed as a contractual after-sales program dedicated to ensuring we use our expertise and technology to help keep the clients purchased asset in a premier operating condition, for its useful life expectancy.
Examples of such may include; Dry Vacuum Pumps Mechanical Seals and Sealing Systems Barrier Isolators Reactors, Agitators, Blenders, Dryers, Filters Please do not hesitate to contact us for further information on our Asset Healthcare Management service.
In addition to providing innovative equipment from our standard product range the Standard Group of Companies offer a range of value-add services, some of which are detailed below.