Multicompendial grade

BUFFER MANUFACTURING

 

Buffer liquids can constitute an expensive bottleneck in bio pharmaceutical downstream processing. Making these liquids in-house requires regulatory oversight, quality management and dedicated space, equipment and staff for buffer manufacturing, preparation and handling.

A&C offers cost effective, flexible and tailored solutions for your buffer outsourcing and cleaning solution needs and always provide full release testing and supporting documentation.

 

At A&C we are experienced in buffer manufacturing and we have the capabilities to manufacture buffers on your behalf in our GMP and ISO 9001:2015 certified facilities*.

We manufacture buffers, process solutions, cleaning solutions, custom liquid blends and Water for Injection (WFI), all in compliance with Good Manufacturing Practices (GMP). Our buffers and solutions meet all the current monographs and compendial grades (USP/EP/BP/JP/Multicompendial) where applicable.

 

Our GMP buffer and ingredient blend portfolio  includes a wide range of products, the majority of which are custom blends , solutions or dilutions. All of our buffers are manufactured utilizing Water for Injection for further processing. Product types include:

  • Phosphate buffer solutions
  • Caustic solutions
  • Salt solutions
  • Acid solutions
  • Solvent blends
  • Acid blends
  • Water for Injection (WFI) for further processing
  • Buffer concentrates

 

If a customer is looking to outsource a propriety product, A&C is experienced in executing the requirements of a technology transfer protocol. High quality standards combined with professional project management make us the best partner for bio pharmaceutical companies looking for reliable buffer and process solutions outsourcing.

A&C has a state-of-the-art GMP manufacturing facility in Ireland dedicated to biological buffer manufacturing and production of process solutions, cleaning solutions, chemical blends and WFI. The Irish facility is ISO 9001:2015 certified and is the only in the country to manufacture biological buffers with Water for Injection.

We also offer GMP repacking and down-packing of liquids and powders in batch specific sizes conceived and designed to meet our customers’ requirements. Custom packaging formats meet FDA and EMEA packaging requirements and range from 10 L to 1,000 L:

  • Single use bio process bags
  • Plastic drums HDPE (various formats)
  • Stainless steel drums (various formats)
  • Smaller sample packaging available
  • IBCs

 

A&C is a partner of choice for pharmaceutical and bio pharmaceutical companies that need to outsource their process solution, cleaning solution and buffer manufacturing. Get in contact with us

 

*A&C’s ISO 9001:2015 certified QMS manufacturing facilities are:
– Site A: 3010 rue de Baene, Montreal, QC H4S 1L2, Canada
– Site B: 20325 avenue Clark-Graham, Baie-D’Urfé, QC H9X 3T5, Canada
– Site C: Grange Business Park, Skule Hill, Fedamore, Co. Limerick, Ireland