02.22.25 -- Aseptic Manufacturing Solutions And Services

The Sterisart® Universal | Gen 4 pump is designed to operate flawlessly within barrier technology environments. It enables precise and contamination-free transfer of samples and media into Sterisart® canisters, essential for accurate sterility testing.

MilliporeSigma offers fully compliant sterility testing according to USP <71>, EU Pharmacopoeia <2.6.1>, and JP Pharmacopoeia <4.06>. Sterility testing is an essential part of validation for products manufactured according to GMP purporting to be sterile.

Paper disc Biological Indicators (BIs) have been used to validate the sterilization of contact lenses in steam where the placement of a strip was impossible due to its size. Mesa offers a full line of BIs to address the unique requirements of the medical device and pharmaceutical industries.

The Stevanato Group EZ-fill® platform has been developed in close co-operation with manufacturers of fill and finish machines to ensure smooth operational processes.

Oval Medical has developed a novel Prefilled Primary Drug Container (PDC) that resolves many drug compatibility and functionality issues associated with the use of traditional glass syringe and rubber plunger technologies, resulting in more reliable products.

Four experiments were conducted and concluded that the Corning® Valor® Glass vial, NovaPure® 4432/50G stopper, and Flip-Off® seal with TruEdge® technology combination is a suitable and reliable container closure combination for frozen drug storage at temperatures as low as -80°C.

At Singota Solutions, robotic aseptic filling is done in a gloveless workcell that provides highly repeatable, precision fills for small batch manufacturing. The system is ideally suited for producing pre-clinical, clinical, and niche commercial injectable products in vial, syringe, and cartridge formats.

Seeking the right partnerships is crucial to help overcome complex challenges. Samsung Biologics takes responsibility for leveraging capabilities, optimizing process efficiency, ensuring successful delivery, and providing the assurance of secure commercial product supply.