Limerick, Ireland: A&C Bio Buffer
A&C Bio Buffer manufactures GMP biological buffers, process solutions, cleaning solutions, Water for Injection (WFI), chemical blends and custom liquid blends in their state-of-the-art ISO 9001:2015 certified manufacturing facility in Ireland. The facility has also been audited by over 15 global customers.
A&C Bio Buffer is a partner of choice for many pharmaceutical and biopharmaceutical companies that decide to outsource their buffer and process solution manufacturing. They provide cost effective, flexible, and tailored solutions for all buffer outsourcing and cleaning solution needs, including localized manufacturing and safety stock availability.
A&C Bio Buffer is part of the A&C Group, which has been servicing the Life Sciences industry since 1966, and also has two GMP manufacturing facilities in Canada. The A&C group is now proud to have joined the Aceto family.
Custom manufacturing and custom solutions
A&C Bio Buffer works with a variety of standard and custom products at its dedicated liquid GMP manufacturing facility in Ireland. Custom products manufactured include buffers, process solutions, cleaning solutions, liquid blends and WFI.
A&C Bio Buffer’s R&D team has experience with complex custom solutions development, and they have successfully completed many technology transfers from customers who wanted to outsource their buffer manufacturing.
A&C Bio Buffer can also provide custom formulations or will duplicate your current formulations, always guaranteeing quality, technical and product reassurance. A&C Bio Buffer can utilize the customer’s current raw material sources to allow easy qualification of materials, or they can select raw materials from their own approved vendors list.
GMP custom packaging
A&C Bio Buffer offers a variety of standard packaging types meeting FDA & EU packaging requirements, as well as custom batch-specific container sizes to suit the customers’ needs.
Packaging formats typically range from 100 mL to 1,000 L and include:
- Single-use bio process bags
- Glass bottles (clear and amber)
- Plastic drums HDPE (various formats)
- Metal and stainless-steel drums (various formats)
- Intermediate Bulk Containers (IBCs)
They also perform GMP repacking and down-packing of raw materials. All the GMP repacking activities are carried out in an ISO class 8 clean room environment.
Quality & Supply
The A&C Bio Buffer team acknowledges the importance of high-quality standards for their clients, which is why quality is at the core of all their activities, and their products and services are developed to meet the most stringent regulatory requirements.
The A&C Bio Buffer GMP facility in Ireland and the two A&C GMP manufacturing plants in Canada utilize a world renowned eQMS that digitizes and automates quality compliance across the companies. This allows for full traceability and ensures that documentation is compliant with GMP and data integrity requirements. A&C’s Quality Management System also ensures that customers receive products that continually meet the quality, purity, safety and suitability for their manufacturing application.
To strictly adhere to pharmaceutical supply chain best practices and to guarantee full supply chain transparency, A&C Bio Buffer provides the complete documentation portfolio required by the industry for all their products