Services
Consultancy Services
Specification and outline design of isolators and Cleanrooms for various applications. Working directly with the users and drawing in AutoCAD, we can produce general arrangement drawings ready for detail design or mock-up construction. P and ID Drawings for Isolators. In parallel with general arrangement design of Isolator, we often produce P and ID drawings which then illustrate how the various isolator sub-systems inter-relate. Design of mechanical, electrical and electronic control, instrumentation and alarm systems.
If required, we can further detail the sub-systems for construction by isolator manufacturers or equipment suppliers. We have experience of working to GAMP (currently GAMP 5). Liaison with isolator manufacturers and equipment suppliers. Having produced outline designs, it makes sense for us to carry the project onwards to fabricators and manufacturers, on behalf of the users. Drafting of protocols such as URS/URB, DQ, FAT, SAT, IQ, OQ, PQ and PPM. Many companies find it easier to sub-contract the drafting of protocols to specialists rather than employ their in-house QA teams. Our protocols are clear and concise. We can work to client format or use our own formats. Execution of DQ, FAT, SAT, IQ, OQ, PQ and PPM protocols on site. We are able to manage the execution of protocols, working in co-operation with independent test engineers. Drafting sporicidal gassing cycle development and PQ protocols. Again, our protocols are clear and concise, avoiding complex statistics and confusing processes. Executing sporicidal gassing cycle development and PQ protocols on site. Cycle development has something of a reputation for being lengthy and unreliable. We aim to clarify the process and complete the work with a minimum of complexity. We can offer assistance at all stages of projects involving isolation technology, from initial concepts through to on-going maintenance, including trouble- shooting on existing equipment.
“If the isolator is to be sporicidally gassed, then the appropriate cycles need to be developed known as GCD (Gassing Cycle Development). Here again, IsoClean services is developing a procedure and test method for our customers for complying to EU GMP and US FDA pertaining Isolation technology)”
Design and Development:
Using our experience of isolator construction and installation, we can offer help with all aspects of isolator design. Right at the outset we can advise on the general layout of the isolator to match the process, be it aseptic, toxic or a combination of both. We can advise on the ergonomics and the practicality of designs for laboratory use.
What would be pressure requirements of the Isolator, positive or negative? Can the process be handled via sleeves and gloves, is a half-suit the best handling solution, or can the process be fully automated? What process equipment must be housed within the isolator and what services does it require? With the general concept agreed, we would then develop the P and ID, ensuring that the pressures and air flows through the complete system are evaluated, and that all the necessary process elements are included, as well as details such as filter PAO test points. Ventilation systems can be unidirectional or turbulent, positive pressure or negative pressure. Clearly these parameters need to be reviewed and logically designed. Control and instrumentation are next for consideration. In some cases, a simple manual system may be suitable while in other cases, a full PLC may be needed to handle control and instrumentation, perhaps integrated with some of the process equipment. We can produce appropriate circuit diagrams, wiring drawings and component lists, as the need arises.
Validation and documentation:
Starting right at the outset of projects, we can help to write the URS (User Requirements specification) by working alongside the client team. Then sent out to equipment manufacturers for quotation, we can help to review the bids and the subsequent FDS (Functional Design Specification). We can then work alongside the client during the DQ (Design Qualification) exercise. Keeping track of the build process and progress may be a problem for the client and so liaison with the chosen manufacturer can be part of the IsoClean Services remit. When the time comes for FAT (Factory Acceptance Test) we can witness the process on behalf of the client. And similarly, at IQ (Installation Qualification) and OQ (Operational Qualification), we can act for the client.
WE PROVIDE BEST SERVICES ABOVE THE WORLD
Training,Research and Development
Instruction on isolator design, construction, validation and operation to suit client needs, including hydrogen peroxide gassing processes Design development and prototype construction for novel isolator-based projects.
Bespoke Isolator Designs & Project Management
Outline design and general arrangement drawings for process-specific isolator projects. Liaison with users and isolator manufacturers, from design concept through to final validation and operation.
Isolator and Cleanroom Consultancy, Products, Validation
All aspects of the design, construction, validation and operation of pharmaceutical isolators. Supply of Isolator sleeves, Gloves, Filters, Glove Leak tester and Other half-suits, flexible film canopies and rapid transfer ports (RTP). Drafting and execution of protocols such as IQ and OQ, gassing cycle development and PPM’s.
