Pharmaceutical manufacturing facility
TriPharm Services, a contract development and manufacturing organisation (CDMO), is developing a pharmaceutical manufacturing centre in Morrisville, North Carolina, US.
The facility will be specialised in manufacturing injectable pharmaceutical products including liquid and lyophilised parenteral products, addressing the need for qualified parenteral manufacturing facilities in the US.
Announced in October 2019, the plan is expected to become fully operational in the second quarter of 2020, generating approximately 50 jobs upon completion.
The manufacturing facility will be situated at 627 Davis Drive, Morrisville, North Carolina, US on the outskirts of Research Triangle Park, which can be reached in ten minutes by road from Raleigh Durham international airport.
TriPharm’s manufacturing centre will cover an area of 32,000ft², 10,000ft² for cleanrooms. It will include state-of-the-art equipment and four isolator filling suites with the highest level of control for Grade A processing of biological and lyophilised formulations.
The facility will also feature eight Grade C and D multi-purpose cleanrooms along with advanced utilities for liquid parenteral formulations and equipment storage. It will have ten air handling units that provide separation for the production activities across each filling suite.
It will feature a full range of GMP storage conditions including walk-ins and reach-in chambers equipped with generators and UPS systems, to ensure that critical operations are maintained during power outages.
The facility will also include a 500l storage tank for storing purified water and 20,000l process water capacity. Purification is based on reverse osmosis and will use an automated loop sanitation cycle. The plant will be equipped with an air compressor, 1,500-gallon nitrogen supply tank, chiller, gas-fired steam boiler, hot water boiler and fire sprinkler system.
Tripharm’s pharmaceutical manufacturing centre will feature Groninger FlexPro 50 and Flexicon FPC 50 isolators equipped with Franz Ziel isolator modules.
The Groninger FlexPro 50 is an aseptic, small-batch isolator capable of processing both high, as well as low-viscosity compounds with minimum line loss. It will offer high flexibility and support syringe capacities ranging between 1ml and 10ml.
The isolator is equipped with two fill nozzles, which can fill 100 to 160-count tubs of ready-to-use (RTU) syringes, while a vacuum-assisted stopper helps to keep viscous liquids bubble-free upon filling. The isolator also supports vapourised hydrogen peroxide (VHP) sterilisation, along with aeration and decontamination.
Flexicon FPC 50 is a flexible, aseptic, small-batch filling machine equipped with stoppering and crimp capping system. It uses peristaltic dispenser for filling, which provides high-dose accuracy for liquid volumes ranging between 2ml and 50ml. The isolator also provides quick changeover between batches and can process up to 25 vials a minute.
Tripharm’s pharmaceutical manufacturing centre is expected to be equipped with lyophilisation equipment featuring automatic load / unload system in the future. The system will support pharmaceutical development through commercialisation.
It will also be equipped with additional liquid filling machines with isolator technology, vial washing facilities and terminal sterilisation capabilities.
Semi-automatic or manual visual inspection capabilities for vials and syringes will be introduced, as well as an onsite in-process laboratory to support analytical and microbiology needs.
TriPharm Services provides fill-and-finish manufacturing facilities for parenteral formulations for pharmaceutical and biotechnology clients. It provides high-quality and unique services to the clients by giving them flexible, reliable and scalable manufacturing options.
The newly established company is financially supported by Ampersand Capital Partners, a private equity firm focused on healthcare.
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