Global pharmaceutical services provider Almac Group completed the expansion of its commercial pharmaceutical manufacturing facility in Craigavon, Northern Ireland, on 20 April 2010.
The £9m ($15m) expansion took over a year to build and increased space at the facility to 120,000ft². The extended facility has been designed to meet increasing demand for integrated pharmaceutical development and commercial services.
The expansion undertaken by the pharmaceutical services division of Almac has allowed the company to double its analytical chemist workforce to 80. The project was supported by Invest Northern Ireland.
The Medicines and Healthcare products Regulatory Agency (MHRA) completed the inspection of the facility by October 2010. The four day inspection, carried out between 13 September and 16 September 2010, concluded that the facility was compliant with the Good Manufacturing Practices set out by the EU.
Almac commercial manufacturing facility expansion
The expansion was carried out in two phases. In the first phase, the existing manufacturing facility was extended by three storeys. Approximately 30,000ft² of space, including new state-of-the-art laboratories and office areas, was added to the existing building. Phase one of the expansion was completed on schedule in June 2009.
The first of the three floors includes the quality control, microbiological and environmental laboratories. These offer a range of services that support the pharmaceutical development offering, commercial manufacture and commercial support services.
The second floor of the extension houses the analytical support laboratories, which provide support services for all pharmaceutical development projects.
Only the first two floors have been outfitted as part of the current project. The third floor will be used for future expansions, depending on business and client needs.
Phase two, completed in March 2010, saw the remodelling of the extended facility. Space for microbiological and sterility testing was expanded and new yellow light labs were installed. Additional office and meeting rooms were also designed during this phase.
The expansion was carried out as part of a larger five-year construction and development programme unveiled by Almac in September 2009. Besides adding laboratory, office and warehousing space to the Craigavon facility, the expansion included the construction of a 240,000ft² facility in Souderton, Pennsylvania.
The $120m Pennsylvania facility contains new analytical labs, and also serves as Almac’s new US headquarters. It was officially opened in February 2011, and is now fully operational. The facility has been designed to offer clinical packaging, drug supply management and technology solutions to clients in the pharmaceutical and biotech industries.
A specialised storage facility was also completed in Craigavon as part of this expansion in late 2010.
The first phase of employee relocation from Almac’s three business units was completed in October 2010. Employees from Almac’s analytical testing and clinical supplies division have also been moved to the new headquarters.
The remaining Audubon-based clinical supplies operations of Almac have been be relocated to the new headquarters in Pennsylvania. The first clinical materials were shipped from the site in November 2010.
The cGMP-compliant Craigavon facility accommodates 100,000 grade D class processing suites with humidity control. It also includes laboratories, an in-process warehouse and space for administration capabilities.
A range of processing equipment at the facility supports different batch sizes to meet the specific product requirements of customers. The facility includes blenders of variable types and sizes. It is outfitted with dry granulators, wet granulators and compressors that operate at a capacity of 15,000 to 300,000 tablets an hour. The facility is also fitted with a range of capsule-filling equipment that is designed with multiple tooling change parts.
The facility is fitted with a fully automated capsule weight-checking machine. Tablet-coating equipment at the facility matches load sizes ranging between 25kg to 350kg. In addition, the plant also has tablet imprinting equipment, which can produce between 50,000 and 300,000 tablets an hour and a range of sachet-filling equipment that can fill between 1g to 15g of dose powder and granules, and produce an output of 300 sachets a minute.
The commercial facility also accommodates multiple packaging suites, which can package solid oral dose products into blisters, bottles, sachets and wallets. The facility also provides secondary labelling and packaging of vials and ampoules at a capacity of 200 vials per minute. A late-stage customisation suite has been dedicated to process products just-in-time for supplying directly to pharmacies.
Technology and production
The facility incorporates a host of advanced technologies for manufacturing pharmaceutical products. During primary processing, the active pharmaceutical ingredient (API) is blended and dry blended. Secondary processing of the API includes dry granulation, wet granulation, particle sizing, compression of directly compressible formulations, encapsulation, coating and tablet imprinting.
The facility develops pharmaceutical products in solid oral dosage form. Tablets are manufactured in immediate and modified release, coated and uncoated, chewable, tab-in tab and bi-layer forms.
Hard gelatine capsules are manufactured while powders are made available in granules and as oral powders for reconstitution. The expanded facility supports the method development, validation and transfer requirements of its customer’s projects.
The pharmaceutical services division of Almac offers product development, clinical batch production, commercial scale manufacturing and packaging and commercial support services. Approved by the FDA and licensed by MHRA (medicines and healthcare products regulatory agency), the division caters to clients in the pharmaceutical and biotechnology industries. It operates a product development facility, a penicillin facility, a cephalosporin facility and a warehouse in addition to the commercial manufacturing facility in Craigavon.