Aseptic/Sterile Processing

Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.

Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.

Advancements in cell culture and protein technology have opened the door for new therapies.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

The need for flexibility and higher quality are driving advances in parenteral manufacturing and fill/finish equipment.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

USP describes analytical and microbiology testing required for different types of pharmaceutical water.

FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.

Robotic fill/finish systems reduce human intervention, improve flexibility, and allow more gentle handling of containers.

The type of water for pharmaceutical use is determined by USP testing.

Bosch’s new system for the production of water for injection uses membrane processing and ultrafiltration.

The Alfa Laval TJ40G tank cleaning machine with a four-nozzle rotary jet head cleans tanks quickly with less water.

Watson-Marlow Fluid Technology Group’s ASEPCO Weirless Radial diaphragm valves eliminate dead legs and product entrapment.

A chlorine dioxide sterilization cycle was developed for a novel split-valve aseptic powder transfer device.

The patented SKAN NANOX Catalysts enable higher efficiency breakdown of hydrogen peroxide at lower temperatures for shorter decontamination cycles.

The new ISPE Containment Manual is a summary of the process involved in the manufacture of highly active or highly hazardous pharmaceutical substances.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

Susan Schniepp, distinguished fellow at Regulatory Compliance Associates,  discusses how to ensure sterility when manufacturing small-scale parenteral batches.

The agency finds repeated CGMP violations at Porton Biopharma, Limited.

The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.

The company was cited by FDA for violations of sterile processing GMPs.

Airlocks, gowning rooms, and transition spaces have different uses and should be considered separately in cGMP pharmaceutical facility design.

Wockhardt Limited received a warning letter from FDA for CGMP violations.