Lifecore’s experts have gained the know-how to build processes around your requirements for smooth scale-up and high-quality manufacturing. Whether we’re your primary partner or a secondary source for manufacturing, we ensure you’re fully satisfied with the final product that bears your brand.
Flexibility:
- Aseptic filling for multiple sizes and configurations of vials, syringes and cartridges.
- Flexible batch sizes.
- Ambient and cooled storage for incoming raw materials and finished products.
Quality:
- Sterile filtration capability of highly viscous materials in excess of 100,000 cP.
- Competent technical transfer with validated production on our equipment.
- Dedicated team of functional experts for continuity and institutional knowledge of commercialized products.
- Complete visual inspection of final goods.
Partnership:
- Supply chain expertise to identify, source, and procure all raw materials.
- Collaboration on primary and secondary packaging and sterilization options.
- Assistance with non-standard components such as enhanced plunger rods or ergonomic finger grips.
Fill and Finish Capabilities:
Formulation – ISO 7 (Grade C):
- Krieger mixing vessels – capable of mixing highly viscous solutions
- Customized DCI mixing vessels – capable of mixing highly viscous solutions
- Mixers can be run in non-sterile or sterile mode
- Ability to incorporate custom mixing equipment dependent on the product characteristics
- Chemical transformations, hydrogel cross-linking and purification unit operations, under sterile conditions
Filtration – ISO 7 (Grade C):
- Sterile filtration capability of highly viscous materials in excess of 100,000 cP.
Filling – ISO 5 (Grade A):
- Fillers:
-
- Flexicon Vial Filler (2R-100R) – Peristaltic Pump
- Optima INOVA Filler (5 Head Syringe Filler- 0.5mL – 10mL) – Rotary Piston Pump (2 Machines Available)
- Optima INOVA Filler (5 Head Flex Filler – 0.5mL – 10mL syringes or 2mL – 50mL vials) – Rotary Piston Pump
- Groninger in SKAN Isolater Filler (5 Head Flex Filler) –– due mid 2023
- Groninger in SKAN Isolater Filler (10 Head Flex Filler) –– due late 2023
- COLANAR – Benchtop Pilot Filler
- Filling capabilities:
- Syringes (0.5-10ml) (RTF)
- Vials (2-50ml) (RTF)
- Bags – custom and standard
Sterilization:
- Experience with ETO, gamma and steam sterilization