Manufacturing

Articles

Formulation residue, observer viewing distance, light intensity, viewing angle, observer viewing position, and observer-to-observer variability affect the ability to confirm the cleanliness of manufacturing equipment.

Application of Visible-Residue Limit for Cleaning Validation

This article provides an overview of the important factors associated with air handling systems within pharmaceutical and biopharmaceutical facilities. It provides information on the need for these systems, design considerations and advice on the approach to commissioning and qualification.

Clean Rooms and Air Handling Systems — Design for Compliance

Possible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, logistics, and maintenance departments, as well as engineering, are involved in the conceptual stages of a design.

Designing & Implementing Pharmaceutical Clean Rooms

New technologies and improvements to existing ones can reduce contamination risk in aseptic processing.

Minimizing Risk Through Technology

A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.

A New Concept in Aseptic Filling: Closed-Vial Technology

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.

The complete elimination of human-derived contamination is possible only with the elimination of human intervention.

Aseptic Processing: A Vision of the Future

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.

Isolator Technology With the Patient in Mind

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.

Study results show that the state of a cleanroom clothing system–new or much used–influences the protection efficacy of the system.

Aseptic Production, Gowning Systems, and Airborne Contaminants

The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.

Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays

The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.

Aseptic/Sterile Processing