Licences
- Investigational Medicinal Products (IMP) Licence
- Manufacturer’s / Importer’s Licence
- Wholesale Dealer’s Licence
- Manufacturer’s ‘Specials’ Licence
- Manufacturer's Veterinary Licence
- Controlled Drug Licence
Equipment/Capabilities
The following list reflects SCM Pharma’s current capabilities only, but our unique approach to meeting individual client requirements allows new equipment to be installed at any time. If we cannot instantly accommodate your requirements, we pledge to go out of our way to create the means to do so.
To demonstrate our scale adaptability, batch sizes can be as small as one unit, up to around 50 kg/200 litres. Clients can select individual modules of SCM’s capabilities or elect to use its full range of professional project management services if a fully outsourced solution is preferred. At present, SCM’s equipment list includes:
Manufacturing/Filling
- Autoclave for terminal sterilisation: double door unit capable of processing liquid and porous loads (Autoclave cycle development activities, along with full validation services).
- Isolator (aseptic processing) through a four-glove, rigid-wall isolator with integrated liquid dispensing and transfer devices for the introduction/removal of materials into sterile isolator. Ideal for the aseptic filling of liquids, powders and topicals and assembly operations.
- Additional isolators currently in development.
- VHP Generator, model 1000 EDs, for the bio-decontamination of isolators integrity-testing equipment, rotary system with fully compliant CFR operating system for the integrity testing of ampoules and vials.
- Integrity testing equipment, CFR 21 part 11 compliant operating system for the integrity testing of ampoules and vials.
- Ampoule filler, suitable for filling open/closed ampoules within a fill range of 0.5-10ml.
- Liquid blending system to routinely accommodate quantities up to 100L though larger quantities (up to 1000L) feasible.
- Capsule filling: manual, semi-automatic and fully automatic fill requirements can be accommodated.
- Freeze drier (with isolator for aseptic processing) from 2009.
Packaging/Storage
- Labelling equipment for the application of self-adhesive labels.
- Artwork generation system for the production of client-specific labels, with the system fully compliant to current CFR regulations and software that also supports labelling requirements for clinical trials.
- Blister packer with wide variety of change parts available and associated feed systems for oral, solid dose products.
- Storage facilities, suitable for pallet sized quantities of materials, under temperature controlled conditions (15-25deg C), with both low and ultra low temperature associate storage facilities (2-8 deg C and -45 deg C).
- Worldwide distribution to clinical centres
