Manufacturing

Theodore H. Meltzer is principle of Capitola Consultancy.

Articles

The authors encourage the investigation into whether the occurrence of grow-through and the diminution in the size of certain organisms when in contact with given liquids are the same phenomenon manifested under different circumstances.

Grow-Through and Penetration of the 0.2/0.22 "Sterilizing" Membranes

Because of the growing popularity of single-use materials, the identification, characterization, and qualification of new materials used for disposable processes have become increasingly important for both regulatory and production purposes. This article describes one approach to identifying and validating the materials used in a disposable filling process.

Characterization, Qualification, and Validation of a Disposable Final Filling Process for Parenteral and Ophthalmic Drugs

Clean rooms are areas in which it is essential that microorganisms are not allowed to proliferate because they could contaminate pharmaceuticals and directly affect human health.

Pharmaceutical clean rooms: specialty hygiene coatings

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 authors present a new approach to risk assessment for aseptic processing that emphasizes the contributions of personnel.

The Akers–Agalloco Method

Robert R. Reich is the president of PSI, 909 Orchard Street, Mundelein, IL 60060, tel. 847.566.9229, fax 847.566.4960, rreich@pharmsystems.com

The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

The Adverse Effects of Cellulosic Material in Isolator Barrier Technology

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 Richard J. Forsyth and Vincent Van Nostrand

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.

Aseptic/Sterile Processing