Sterile Capability at the Core of SpectrumX
Sterile pharmaceutical manufacturing sits at the heart of the SpectrumX CDMO proposition.
Our facility combines controlled manufacturing environments, specialist production technology and pharmaceutical expertise to support sterile programmes from development through to scalable manufacture.
Current Capability
Sterile Fill-Finish
Controlled sterile manufacturing supported by specialist filling, sealing, inspection and terminal sterilisation infrastructure.
- Sterile glass vials
- Glass ampoules
- Other suitable formats subject to technical assessment
Current Capability
Terminal Sterilisation
SpectrumX's pharmaceutical manufacturing infrastructure includes autoclave capability supporting terminal sterilisation where appropriate to the product and manufacturing process.
Up to 10,000 units/day
Terminally Sterilised Ampoules & Vials
Visual Inspection
SpectrumX has in-house visual inspection capability supporting terminally sterilised vial and ampoule manufacture.
100% visual inspection
Integrated Inspection Capability
Container Closure Integrity Testing
CCIT capability supports vial and ampoule presentations as part of SpectrumX's integrated sterile manufacturing infrastructure.
CCIT
Vials & Ampoules
Aseptic Capability
SpectrumX's aseptic filling capability is installed and in final qualification within our existing UK sterile pharmaceutical manufacturing facility.
The expansion is being developed within an established Pharmaceutical Quality System and operational sterile manufacturing environment.
- ORABS aseptic filling line
- Grade B/A filling environment
- IHP bio-decontamination process
167 vials/min
ORABS Line Design Throughput
Technology transfer discussions and programme planning can begin ahead of future commercial aseptic supply, subject to successful qualification, regulatory approval and product-specific validation requirements.
Looking for a Sterile Pharmaceutical Manufacturing Partner?
Whether you are developing a new product, transferring an existing programme, preparing for scale-up or looking for a long-term manufacturing partner, speak to SpectrumX about your requirements.