Manufacturing

Articles

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

Avoiding Contamination Risks in Aseptic Processes

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

Isolated Robotics: The Future of Aseptic Operations

Henrik Schwartzbach is a Senior Process Technologist at GEA Niro.

Henrik Schwartzbach, senior process technologist at GEA Niro, explins why spray drying is seeing increased uptake in the pharma industry.

Achieving Aseptic Drying With Spray Drying Technologies

The author describes the components that make up a clean-in-place system and how the system should be built to ensure efficiency.

Basic Equipment-Design Concepts to Enable Cleaning in Place: Part II

The author describes the benefits and challenges inherent to cleaning in place (CIP). The article also describes the development and validation of a CIP cycle.

Basic Equipment-Design Concepts to Enable Cleaning in Place: Part I

Orlando LÃ³pez is a senior consultant at McNeil Consumer Healthcare, a J&J company.

To help you get up to speed with the ins and outs of the amended version of Annex 11, which will come into effect on 30 June 2011, PTE brings you two articles that take a close look at the amendments.

Annex 11 Articles

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

A Comparison of Polymeric Flooring and Disposable Mats in Pharmaceutical Cleanrooms

Carolina Krevolin is a category manager for scientific gloves at Kimberly-Clark Professional.

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.

Glove Selection for Controlled Environments

Dave Abram is manager of validation and technical services at BioConvergence LLC, 4320 West Zenith Drive, Bloomington, IN 47404, tel. 812.961.1700, fax 812.961.1733.

The author details the factors in formulation design, requirements in facilites and equipment, and validation criteria for aseptic formualtions.

Current Perspectives on Aseptic Formulations

Theodore H. Meltzer is principle of Capitola Consultancy.

Jean-Marc Cappia is vice-president of marketing for fluid management technology at Sartorius Stedim Biotech FMT, Aubagne, France.

The authors discuss current and future disposable technologies and outline the validation and qualification steps that would be required for a possible disposable process stream.

Aseptic/Sterile Processing