BPE has deep insight and multiple references into high containment sterile manufacturing projects. We have first-hand experience operating in fill-finish environments, extensive knowledge of regulatory developments (Annex 1), practical experience integrating different filling technologies and awareness of the industry’s most recent developments.
Our expertise is across:
- Peptides (Extraction, Purficiation and Lyophilisation)
- High Containment (High potency/ATEX/Isolators)
- Plug and Play (Skid Build for future optimisation)
- Fume Hood Processing (Segregation/Mitigation)
- RABS (Sterile/Aseptic Processing)
Our expertise has allowed us to execute projects in sterile, aseptic and containment environments recently undertaking several sterile injectable facility projects.
- High Containment OEB6 Lab Scale Suite – €10M
- Sterile Injectable Facility – €35M
- rFSH and Peptides Facility – €30M
- High Speed Aseptic Filling RABS – €10M
- Peptide Purification Suite – €25M
- Sterile Antibiotic Injectable Facility- €10M
- New QC Sterility Labs – €5M
- New Compounding Suite – €20M
KEY INDUSTRY TRENDS
- Automation for high speed filling and robotics
- Annex 1 revision of WFI states it must be produced from purified water instead of drinking water. The EU Pharmacopoeia also recommends the use of reverse osmosis to produce WFI, but regulators prefer distillation
- Desire for flexibility is growing to help anticipate future format, packaging and filling needs
- Filling Line Delivery 18-22 Months
RABS VS ISOLATOR DESIGN
Open Rabs/Closed Rabs
- Environment B
- No overpressure to surroundings
- Complexity: High, due to transfer techniques and restricted access by gloves
- Comfort: Even lower due to clean room garment and restricted access
- Aseptic quality: Slightly improved SAL-10~10-4
- Several days multiple Batch filling unusual
- Environment D
- Over pressure
- Complexity: Highest, due to transfer techniques and bio-contamination
- Comfort: Medium, no clean room garment but some restrictions
- Aseptic Quality: Highest SAL~10-6
- Weeks Multiple batch filling possible
KEY DESIGN CONSIDERATIONS
- RTP connections, cleaning, equipment disassembly, maintenance – key risk points.
- Containment philosophy needs to be specific with each material transfer into/out of isolators fully assessed.
- Basis of safety – key controls are procedure, operator training, routine IH monitoring to assess performance.
- 3D visualisation/mock-ups with isolator vendor for ergonomic design is key success factor and adoption of design.
- Risk assess and eliminate hazardous zones where possible.
- Automation integration – networking of TCUs, pluggable instrumentation, paperless batch recording.
This article is taken from our May newsletter which you can read here. To discuss your high containment needs please contact Aisling Crowley, Client Relationship Manager on +353857441155 or fill out our contact form here