Sterile services (manufacturing and filling)
In our cleanrooms, we continue to provide clients with a wide range of sterile manufacturing and sterile filling services – both terminal sterilisation and aseptic processing. Our innovative cGMP-compliant facility also houses a self-contained suite for the processing of potent materials with the capability to process a wide range of dosage forms. To demonstrate our scale adaptability, batch sizes can be as small as one unit, up to around 200kg/litres. We provide the following sterile production services:
Aseptic processing
The product is sterilised either by gamma irradiation or is made up as a liquid and sterile filtered into a sealed gassed isolator then processed/filled into the final container. Click here to find out more information about our aseptic processing and filling services.
Terminal sterilisation
The product is manufactured under Clean (Class C) conditions, filled into the final container, then sterilised by heat (in an autoclave) or gamma irradiated. We specialise in small-medium scale terminal sterilisation/autoclaving, non-routine/unique loads, validation and cycle development.
We deal with ampoule, vial, bottle, infusion bag and syringe filling for liquids, gels and powders. We can also offer consultancy relating to terminal sterilisation if you would like our team to assist you with your existing or planned process.
Approximate batch sizes for terminal sterilisation -
• 2/3ml vials up to 6,000 vials per load
• 5ml vials up to 4,000 vials
• Batch sizes can be increased by increasing the number of autoclave loads
SCM can also provide gamma irradiation and e-beam sterilisation via our licensed sub-contractor.
We can offer you the following services for the production of sterile products -
Aseptic processing
The product is sterilised either by gamma irradiation or is made up as a liquid and sterile filtered into a sealed gassed isolator then processed/filled into the final container. Click here to find out more information about our aseptic processing and filling services.
Terminal sterilisation
The product is manufactured under Clean (Class C) conditions, filled into the final container, then sterilised by heat (in an autoclave) or gamma irradiated. We specialise in small-medium scale terminal sterilisation/autoclaving, non-routine/unique loads, validation and cycle development.
We deal with ampoule, vial, bottle, infusion bag and syringe filling for liquids, gels and powders. We can also offer consultancy relating to terminal sterilisation if you would like our team to assist you with your existing or planned process.
Approximate batch sizes for terminal sterilisation -
• 2/3ml vials up to 6,000 vials per load
• 5ml vials up to 4,000 vials
• Batch sizes can be increased by increasing the number of autoclave loads
SCM can also provide gamma irradiation and e-beam sterilisation via our licensed sub-contractor.
We can offer you the following services for the production of sterile products -
- Ampoule, vial, bottle, infusion bag and syringe filling; aseptic and terminally sterilised
- Aseptic liquid and powder filling (including radio-labelled compounds, biologicals and topical products)
- Suspensions, creams, ointments and gels
- Isolator technology for specialised aseptic filling activities (designed around each client’s individual process needs)
- Autoclaving services including cycle development and validation
- Cytotoxic formulations and cytostatic products (dedicated area with its own air handling and water systems)
- IMPD preparation and control
- Drug device combinations that may require aseptic assembly and filling
- Products may require low temperatures or be sensitive to light which may have to be controlled during processing
- Scale up of novel dosage forms
- Regulatory advice
- Technical support service
- Formulation services
- Audit of suppliers
- Equipment and process validation
- QP services
- Self-contained suite for the processing of cytotoxic materials
