Aseptic/Sterile Processing

Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines.

Blow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.

The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

Avantor plans to increase its single-use manufacturing footprint by 30% and double its cleanroom space in the US and Europe.

ILC Dover’s soloPure flexible aseptic isolator creates a closed environment for sterile filling.

Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

Traditional methods of testing cleanroom garments fail to test for dynamic conditions in the cleanroom. A holistic approach considers particulate shedding and heat load during processing, as well as the impact of laundering on garment life cycle.

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

ReFIBE sterile cleanroom wipes are sustainable polyester wipes made from recycled post-consumer plastic bottles.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

Consider a matrix of factors when choosing what type of cleanroom facility to construct.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The IsoAir Pro-E Remote Particle Counter by Particle Measuring Systems works to streamline cleanroom monitoring while complying with global regulations.

A holistic approach to validation and quality assurance is essential.

An optimal engineering design is crucial for aseptic operation and cleaning.

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Beckman Coulter Life Sciences announced that its MET ONE 3400+ portable air particle counter is now available for cleanroom compliance.

The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.

The Faciliflex Express product line can be commissioned in six months, making it ideal for cell and gene therapy companies that need to rapidly bring their therapies to patients.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient.