Aseptic processing (using isolator technology)
Within our innovative current GMP-compliant facility, we are able to provide you with small-medium scale aseptic processing and filling. We are licensed for aseptic manufacture of Investigational Medicinal Products (IMP) and offer you a bespoke design service for isolation technology engineered around the process idea for handling proteins and similar temperature sensitive molecules.
Our aseptic fill/finish capability and isolator technology allows for aseptic powder filling and the filling of radio-labelled molecules and products such as biological molecules which cannot be terminally sterilised. We can handle complex and specialist aseptic projects and also provide you with a complementary full range of associated analytical and testing services.
Using isolator technology within our Grade C (class 10,000) cleanrooms, we are able to deliver greater quality assurance than traditional aseptic processing methods. Our self-contained suites allow us 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. SCM Pharma can produce a wide range of aseptic products, including:
• Liquids either in vials, ampoules, bottles or infusion bags;
• Pre-filled syringes containing liquids or gels;
• Suspensions, creams, ointments and gels;
• Powders filled into vials;
• Drug device combinations that may require aseptic assembly and filling;
• Products that may require low temperatures or be sensitive to light, exposure to which may have to be controlled during processing.
Using our 4-glove isolator, approximate batch size capabilities are:
• 2/3ml vials up to 1500 vials
• 5ml vials up to 1200 vials
• 10ml vials up to 750 vials
• Batch sizes up to 30,000 units can be produced in larger isolators
To demonstrate our flexible nature, we can manufacture dedicated isolators to fit around your process and can also use disposable isolators for processing potent materials. We also offer aseptic consultancy if you would like our team to assist you with your existing process.
As your outsourced partner for aseptic fill/finish, you can feel confident our highly-qualified and experienced experts will deliver your project within your desired timescale and available budget. If selected as your partner, we will be happy to help with technology transfer, document generation and all associated set-up.
With our ongoing staff training programme and superior quality standards (with constant environmental monitoring), rest assured your aseptic project will be in a safe pair of hands.
For more information about our aseptic services, click here to get in touch.
Our aseptic fill/finish capability and isolator technology allows for aseptic powder filling and the filling of radio-labelled molecules and products such as biological molecules which cannot be terminally sterilised. We can handle complex and specialist aseptic projects and also provide you with a complementary full range of associated analytical and testing services.
Using isolator technology within our Grade C (class 10,000) cleanrooms, we are able to deliver greater quality assurance than traditional aseptic processing methods. Our self-contained suites allow us 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. SCM Pharma can produce a wide range of aseptic products, including:
• Liquids either in vials, ampoules, bottles or infusion bags;
• Pre-filled syringes containing liquids or gels;
• Suspensions, creams, ointments and gels;
• Powders filled into vials;
• Drug device combinations that may require aseptic assembly and filling;
• Products that may require low temperatures or be sensitive to light, exposure to which may have to be controlled during processing.
Using our 4-glove isolator, approximate batch size capabilities are:
• 2/3ml vials up to 1500 vials
• 5ml vials up to 1200 vials
• 10ml vials up to 750 vials
• Batch sizes up to 30,000 units can be produced in larger isolators
To demonstrate our flexible nature, we can manufacture dedicated isolators to fit around your process and can also use disposable isolators for processing potent materials. We also offer aseptic consultancy if you would like our team to assist you with your existing process.
As your outsourced partner for aseptic fill/finish, you can feel confident our highly-qualified and experienced experts will deliver your project within your desired timescale and available budget. If selected as your partner, we will be happy to help with technology transfer, document generation and all associated set-up.
With our ongoing staff training programme and superior quality standards (with constant environmental monitoring), rest assured your aseptic project will be in a safe pair of hands.
For more information about our aseptic services, click here to get in touch.
