Manufacturing

Articles

Performing D-value and population verification is critical in the acceptance criteria for allowing a new lot of biological indicators into a facility before acceptance and use of the lot in validation work or routine monitoring of sterilization cycles. 

Guidance for Verification of Biological Indicators: Understanding the Acceptance Criteria of D-value and Population Verification

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed. 

Process Considerations for Cell-Based Influenza Vaccines

Adding a cleaning step to the field-testing protocol, and combining it with the data generated to register sanitizing and disinfectant agents under FIFRA and the CEN TC 216 work program, produces a sanitation-and-disinfection validation methodology that is cost-effective, simple, and time-saving.

What is Disinfectant Validation?

Analytical tools and methods that require less water and detergent are gaining interest for faster, more efficient cleaning. 

Pursuing Efficiency: New Developments in Cleaning Technology

Theodore H. Meltzer is principle of Capitola Consultancy.

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.

Aseptic/Sterile Processing