Brecon Pharmaceuticals - Packaging and Distribution Services

Brecon Pharmaceuticals is a fast-growing, quality provider of packaging services to the pharmaceutical and healthcare industries, and is based in modern, purpose-built premises in a quality environment on the edge of the Brecon Beacons.

PACKAGING, STORAGE, DISTRIBUTION AND CLINICAL TRIAL SERVICES

Brecon provides the highest quality commercial packaging, storage, distribution and clinical trial services including:

• Blister packaging
• Thermo-form
• Aclar, alu/alu (cold-form)
• Strip packaging
• Sachet filling
• Heat-seal walleting
• Bottle filling
• Tablet counting

Our analytical services include:

• Stability testing
• Studies to full ICH standard
• Method validation
• Further development and updating of methods
• Extra validation to GMP standards as required
• Extensive report writing service covering protocol generation, certificates of analysis, method transfer, validation and ICH stability reports

Our QP Services include:

• EU Product Release
• API Manufacturing Audits
• Dosage Form Audits
• CMC Consultancy

Brecon's clinical trial supplies include:

• Phase I-IV open / blinded
• Multi-centre
• Multi-country studies
• Label design and compilation
• Cold-chain storage and distribution
• Returns and evaluation including reconciliation
• Manufacturing Phase I/II

We can provide specialist handling for:

• Cytotoxics
• Controlled drugs (vault),
• High potency (separate unit),
• Penicillin (separate unit)
• Biologicals (separate unit)
• Low humidity
• Cold-chain cold storage 2°C to 8°C and down to -70°C

INVESTIGATIONAL MACHINE PACKAGING, STORAGE AND DISTRIBUTION

Brecon was one of the first companies in its field to be given compliance approval by the Medicines and Healthcare products Regulatory Agency (MHRA) for the packaging, storage and distribution of investigational medicinal products.

Brecon was the first company in the UK to be approved as an assessment centre for assured competence. This certification is for operators qualified to NVQ Level 2 in packaging operations and provides assurance of ongoing proficiency.

PACKAGING AND WAREHOUSING FACILITY

Brecon recently opened a new state-of-the-art packaging and warehousing facility, which increases its capacity to 126,000ft². Within the new facility, Brecon has installed a tenth Romaco blister packer. The platen-sealing Noack 623 has been installed as part of a complete line also incorporating a Romaco Promatic PC 4200.

Steve Kemp, business development director at Brecon, underlines the importance of equipment flexibility. "We need to be able to accommodate a wide range of batch sizes – on the one hand, many small batches for delivery to different markets, while on the other, we can help reduce costs as customers use outsourcing strategically. We must also address job-specific requirements, such as complex mixed fills, or the use of special materials, such as those designed for compliance with recent legislation."

AUTOMATED PHARMACEUTICAL PACKAGING PRODUCTION

Britain’s leading packaging innovator, Burgopak, has joined forces with Brecon in a deal that will improve the production of pharmaceutical packaging. Until now, Burgopak has relied on hand assembly to build its pioneering packaging. In partnership with Brecon, however, production will be automated, with each new machine capable of producing a minimum of twenty million units annually.

EXPANDING ITS QP SERVICE

To support the expansion of its EU product release testing and QP services, Brecon has appointed Dr Ken Caldicott as a consultant. Ken is a chartered chemist, a Fellow of the Royal Society of Chemistry and a registered Qualified Person (QP).

Ken will be assisting the company in expanding its EU product testing services and supporting the increasing volume of work of its team of six QPs. He will provide advice in all areas of Chemistry, Manufacturing and Control (CMC) and QP related activities.