Aseptic/Sterile Processing

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.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

The agreement will combine Rentschler’s experience in drug substance manufacturing and Vetter’s expertise in aseptic fill/finish and secondary packaging.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

Regulators have exaggerated expectations for simulated media fills.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination.

Regulators have exaggerated expectations for simulated media fills.

Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.