A&C Bio Buffer’s R&D team has experience with complex custom solutions and have successfully completed many technology transfers from our customers who are wishing to outsource their buffer manufacturing. A&C works with a variety of products at its dedicated liquid GMP manufacturing facility in Ireland and its two GMP manufacturing facilities in Canada.

All products will be supplied with a full-dossier of documents to support your regulatory filings. High quality standards combined with professional project management and competitive pricing makes us a natural choice for pharmaceutical companies looking for reliable buffer outsourcing. Our project management approach, based on effective and transparent communication, gives our clients a guarantee that they will have full confidence in the outsourced activities.

CUSTOM SOLUTIONS

A&C Bio Buffer is the number one choice for many pharmaceutical and biopharmaceutical companies to outsource their buffer and process solutions. A&C Bio Buffer’s facility in Ireland is ISO 9001:2015 certified and is state-of-the-art designed to meet the GMP and GDP requirements. Our two facilities in Canada are FDA audited, Health Canada licensed and EXCiPACT approved.

A&C can provide custom formulations or will duplicate your current formulations, allowing quality, technical and product reassurance. A&C is experienced in completing technology transfer protocol from customers wishing to outsource their buffer manufacturing operation which allows for full confidence in the outsourcing process. A&C are willing to utilize customer’s current raw material sources to allow easy qualification of materials if required, or will only select raw materials from its own approved vendor list.

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CUSTOM AND TRANSPORTATION PACKAGING

Custom Packaging

A&C Bio Buffer has a variety of packaging types that meet FDA & E.U. packaging requirements. Packaging sizes range from 1 L to 1,000 L and include:

  • Single use bio process bags
  • IBCs
  • Plastic drums HDPE (various formats)
  • Metal and stainless steel drums (various formats)
  • Glass bottles (clear and amber)

A&C Bio Buffer utilizes with one of the world leading single-use custom Bio-bag manufacturers allowing A&C to provide robust, secure fluid handling options. Bio-bag are available in standard sizes in 2D end-ported designs (from 50 mL to 20 L), face-ported 2D designs (from 5 L to 200 L) and 3D designs (from 100 L to 1000 L). Custom Bio-bag assemblies in 1,000 L+ for customer-specific requirements can be designed on request. Bio-bags can be fitted with customer-specified tubing lengths, connectors and end fittings providing an identical outsource option to current internal processes. 

Transportation Packaging

Rigid transport and shipping containers are available in standard sizes of 100, 200, 500 and 1000 litres to fit the standard 3D bio-containers. These durable plastic outer containers are reusable and collapsible for storage and handling when not in use. Custom stainless-steel carts provide enhanced mobility for both empty and fully deployed rigid outer containers.

When used in combination, the single-use systems portfolio of Bio-bag deployed in the rigid outer containers allows robust fluid management solutions. These are ideally suited for intra-facility transfers and inter-facility transport of buffers, process solutions and bulk product, or simply as a cost-effective alternative to stationary stainless-steel storage bins.

The rigid outer containers have been qualified for liquid transport in accordance with International Safe Transit Association (ISTA) Series 3 testing. 

Custom Bio-bags can be designed to meet the requirements of customer’s existing transport containers and bioprocessing systems if required.

Every product we manufacture is backed by the expertise of our professional customer service, technical service and field representatives. Our staff is trained to meet your service needs whether they are in custom packaging, specialized delivery, follow-up or consulting. We will help our clients match their formulations with their packaging requirements to fit their unique system. We can also aid in addressing our client’s specific inventory needs and issues. From the time of purchase to the day of shipment, our team will fully support our clients and their product.

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