Aseptic/Sterile Processing

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.

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

The company’s new Milliflex Oasis System provides enhanced result reliability, increased productivity, and advanced traceability.

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.

Past mistakes and misstatements have adversely influenced industry decontamination practices with vapor phase hydrogen peroxide, and this article endeavors to clarify the process.

Ready-to-use components help compounders and manufacturers of small batches overcome economy-of-scale limitations in aseptic GMP manufacturing.

Optima Packaging explains its approach to process design.

Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.

The new device decreases the chances of filter leaks and room contamination while ensuring the lowest possible energy consumption.

The venture will focus on single-use and modular systems designed to develop novel biotherapeutics.

Nephron Pharma and the University of South Carolina plan to build a sterile compounding lab at the University for research and training.

The company is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level because of a lack of confirmation of sterilization for some vials from this lot.

Equipment and systems for aseptic transfer and manufacture meet cGMP and Annex 1 requirements for pharmaceutical fill and finish.

Optima Pharma opened a new assembly hall, the CSPE Center, that will give the company space to build complete, multi-story pharmaceutical manufacturing facilities.

Nephron Pharmaceuticals is partnering with Clemson University to create a robotic solution for syringe-filling automation to enhance sterile manufacturing.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.

Lonza Pharma & Biotech announced a binding contractual commitment for the purchase of a sterile drug product fill and finish facility.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.

A US District Judge in the Southern District of Florida held that the US Stem Cell Clinic of Weston, FL and US Stem Cell of Sunrise, FL adulterated and misbranded a stem cell drug product made from a patient’s adipose tissue.

The US Pharmacopeial Convention released new and revised standards for compounding nonsterile medicines, sterile medicines, and radiopharmaceutical drugs.

Particle Measuring Systems’ new Pharmaceutical Net Pro cleanroom monitoring software for data and collection management and automation offers flexible integration options and intelligent features such as facility mapping, alarming, reporting, and recipe-driven sampling.

The company is voluntarily recalling Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), to the consumer level because microbial growth was detected.

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

Empty and prefilled syringes must pass a range of quality control tests.