Aseptic Filling Process - Sterile Fill-Finish Manufacturing
Producing parenteral dosage forms of small and large molecules from preclinical product development to commercial launch
Alcami has over 23 years of experience in developing and manufacturing liquid and lyophilized injectable drug products, including suspensions, emulsions, & controlled substances in both vials and syringes.
Parenteral manufacturing can be an extremely complex process and pharmaceutical companies need a partner who understands those intricacies and can help successfully scale their process. A recent dramatic increased demand in the pharmaceutical industry has also created a number of unique challenges and investments in extensive planning, trained personnel and highly specialized facilities and equipment.
The success of sterile fill-finish manufacturing relies on mitigating contamination from multiple sources - personnel, drug product components and container systems, cleanroom facilities, equipment and process. As new and complex drugs become more common, it is critical to partner with a trusted CDMO that has years of experience and a track record of success with clients. This will ensure that your product can be produced on a large scale.
Alcami’s parenteral manufacturing sites are based in Charleston, South Carolina and Morrisville (RTP), NC. and support clinical production through commercial launch and supply. Our Charleston site is fully US- and EU-compliant and this DEA-licensed sterile manufacturing facility has been fully integrated with our Wilmington, North Carolina packaging and distribution center for over 22 years.
Our state-of-the-art fill-finish manufacturing facility in Morrisville/RTP, NC expands our sterile drug product capabilities. This 32,000 ft2 location includes isolator manufacturing capabilities for liquid syringes, liquid and lyophilized vials and has also been inspected by the DEA.
Our dedicated staff has the knowledge and skills to help advance your product to clinic and market and you can trust Alcami to bring your product and company to the next level.
CHARLESTON, SC CAPABILITIES
Suspensions & Emulsions
- Dedicated to parenteral manufacturing and laboratory support services
- OEL Levels: Down to SafeBridge Categorization (3A) = > 1-10µg/m3
- Sterile solutions, suspensions, and emulsions
- Grade A and Grade B areas: Filling, capping, sterilized component staging
- Grade C: Compounding, component, preparation, microfluidization, sampling/dispensing
- Grade D: Equipment washing and quarantine storage of cleaned equipment
- Development and filling of DEA Schedule I-V and List I Chemicals
- 100% visual inspection
- FDA, EMA, MHRA, PMDA, and cGMP-compliant
RTP, NC CAPABILITIES
Formulation Development, Tox Material, Client-collaboration workspace & Analytical Testing
0.5mL - 3mL
2R - 30R
- Four cGMP filling lines with isolator technology for filling liquid and lyophilized vials and liquid syringe products
- Low line loss, single-use systems for compounding and product transfer processes
- Terminal sterilization for vials
- Nitrogen sparging and overlay capabilities in both syringes and vials
- Incoming materials & finished product storage temperatures: -80°C, -20°C, 5°C, controlled room temperature (CRT), and customized temperatures
- OEL levels: Down to SafeBridge categorization (3A) = > 1-10µg/m3
- 100% visual inspection
- On-site laboratory support with non-GMP filling capability to support vials and pre-filled syringes for tox material and GLP testing.
- Lyophilization Cycle Development Center & Client-collaboration workspace for facilitating technical transfers
- Filling of DEA Schedule III-V controlled substances
See inside our Morrisville/RTP aseptic processing facility
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