Manufacturing

Louis Rey, PhD, is biologist, scientific and industrial adviser, and lyophilization pioneer based in Switzerland.

Articles

In view of the nature of its complexity, it might be desirable to apply FDA's process analytical technology to lyophilization.

Lyophilization is not a freeze-dried technology

UK science has an outstanding record and we remain strong internationally in terms of achievement, productivity and efficiency.

Science and innovation is the UK's future

Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.

Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

This article summarizes changes to the Akers–Agalloco aseptic processing risk analysis model (first presented in Pharmaceutical Technology's November 2005 issue) as well as some of the underlying thinking behind the revision. The simplified model makes the method easier to use because of its greater flexibility of environmental control practice. It maintains the emphasis on human activity as the primary consideration in risk management for aseptic processing. 

The Simplified Akers–Agalloco Method for Aseptic Processing Risk Analysis

Any aseptic processing technology that allows intervention by gowned personnel during operation cannot be considered an advanced technology. Although a standardized definition of restricted access barrier systems has been developed, these systems fall well short of being classfied as advanced technologies. 

RABS and Advanced Aseptic Processing

The author explores the importance of the proposals to revise Annex 1 of the EU GMPs in the context of the desire for science-based, internationally respected GMPs. Commentary also is provided about the relationship between this annex and CEN–ISO cleanroom standards. 

Effects of the 2006 Proposed Revisions to Annex 1 of the European Union Good Manufacturing Practices

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

Theodore H. Meltzer is principle of Capitola Consultancy.

Model organisms are useful when validating sterile filtration, but successful retention of the model organism does not always guarantee that effluent is sterile. The authors explore the various factors that influence sterile filtration. 

The Use of Model Organisms in Sterilizing Filtration

Berit Reinmuller is a senior researcher in building services engineering at Kungl Tekniska Hogskolan, SE 10044 Stockholm, Sweden, tel. +46 8 790 7537, fax +46 8 411 8432, berit.reinmuller@byv.kth.se. She is also a consultant for the cleanroom industry.

Calculations show the predicted contamination levels in cleanrooms with turbulent mixing air and with vertical unidirectional airflow when people are dressed in modern cleanroom clothing systems. Comparisons are made between operation theatres and cleanrooms. 

Predicted Contamination Levels in Cleanrooms When Cleanroom-Dressed People Are the Contamination Source

Yasusuke Oshima is senior chief engineer at RP System Division, Shibuya Kogyo Co., Ltd.

The industry has acknowledged only recently the significance of the contamination risk posed by humans. The authors assert that this realization, together with technological advances, will lead to the elimination of human intervention and, hence, improved sterility. 

The Next Generation of Aseptic Processing Equipment

There are few, if any, valid reasons not to install an isolator in a new aseptic processing facility. 

Aseptic/Sterile Processing