Purified Water is used as an excipient in the production of nonparenteral preparations and in other pharmaceutical applications, such as cleaning of certain equipment and nonparenteral product-contact components.
Many laboratory water supplies are unreliable and cause problems with contamination, down-time etc. When alternative supplies are sort they typically involve manual dispensing from 55 gallon or 200 liter open drums.
Chata Biosystems, Inc. now offers a closed system for storage and delivery of USP Purified Water 50L, 100L, 200L drums and 1,000L totes. The system consists of three separate parts:
1) an internal bag (the CHEM+NECT bag)
2) tubing and valving system for product delivery
3) cGMP filling process
Chata Biosystems, Inc., has developed a solution that includes using its proprietary packaging technology utilizes a muti-layered, sterilizable bag, (sterilized via gamma and e-beam irradiation) that meets USP Physicochemical and Biological Class VI requirements.. The bag material is chemically inert, has extremely low levels of extractables, low moisture-vapor transmission rate and does not contain chlorine or DEHP plasticizers. As such, the bags can be used with a wide range of solutions.
CHATA’S valve and connecting system is comprised of state of the art connectors that are compatible with water and most buffers, as well as most standard organic solvents. The tubing for the solvent based products is Teflon®, while tubing used for the large volume USP Purified Water and buffer packaging is Tygoprene XL-60.
All CHEM+NECT bags are sterilized prior to filling using gamma irradiation. The appurtenant tubing, bulkheads, and valves/plugs, are also sterilized. The bag, the external container, and the delivery system are assembled in Chata’s Class 10,000 clean room in compliance with cGMP regulations. The required solutions are then introduced into the CHEM+NECT bag through a filter, typically a 0.22 micron filter dependent upon the application, and via a closed connecting system to create the final product. The smaller volume CHEM+NECT packaging is typically vacuumed overwrapped and supported by fiber boxing. The large volume water and buffer solutions are supported by a variety of packages. For laboratory and non-production applications the typical support packaging is 50 or 100 Liter fiber drums. For other applications such as production or pilot plant operations, USP Purified Water or buffers are typically packaged in 50, 100, and 200 L High Density Polyethylene drums. In addition, CHATA provides 1000 L water or buffer solutions in CHEM+NECT bags supported by a collapsible re-usable composite plastic tote.
The CHEM+NECT closed system ensures that as the solutions are removed from the CHEM+NECT bag system; the bag collapses without air intrusion into the contained solution. The external packaging remains unchanged and continues to support the bag throughout the delivery and also acts as a containment system in case of leaks. The bag remains closed throughout its use and is not exposed to the laboratory/production environment.
