Little in life can be as arduous as wading through a chapter from the USP. The minimum practice and quality standards laid out in USP <797> may never be a New York Times bestselling book, but many do look for a better way to understand the cumbersome language of regulatory texts.
By the time this article goes to print — and if the snow ever leaves the ground in New England...
Oral dosage form development in early clinical phases.
Some of the simplest things in a clean area are the cleaning and sanitizing solutions. Normally, we have only to prepare, control, and dispense these solutions properly, so that we can guarantee that they will do what they are supposed to do. But this simple action has many points to consider so that they do not become oversights.
Ensuring the sterility of drug products in vials during the drug packaging process is crucial to drug quality. Keeping injectable drugs safe from, for example, biological contamination, is important as any bioburden could present a significant risk to patients. However, achieving sterility while complying with regulatory standards and increasing operational efficiency can be a challenge for any drug manufacturer.
Opportunities in pharmaceutical manufacture occur at interfaces. The interfaces are not physical borders of cells or product surfaces, but rather conceptual areas where ideas and/or technologies must be blended. Pharmaceutical manufacture has the advantage of having well-established standards and best practices.
Aerospace facilities utilize cleanrooms to control the bioburden and contamination of spacecraft. Planetary protection is necessary in order to detect cultivable and non-cultivable microorganisms, as well as to collect samples from outer space that may contain traces of life.
Controlled Environments spoke with Jan Eudy, Cleanroom/Contamination Control Consultant as well as a Fellow and Past President, Institute of Environmental Sciences and Technology. Eudy is the author of the CE column “Ask Jan” and regularly contributes other articles to our publication.
Controlled Environments spoke with Jim Polarine, MA, Technical Service Manager with STERIS Corp. (Life Sciences division) in St. Louis, Mo.
When it comes to your spoken communications, planning and preparation allows you to deliver your message more effectively, increasing the likelihood others will respond as desired.
Five questions to help you find happiness at work and in life.
Controlled Environments spoke with Chris Muller, Technical Director with Purafil in Doraville, Ga. He is also an ASHRAE Distinguished Lecturer.
A Q&A about pharmaceutical cleanrooms.
The design of a cleanroom should be a well-orchestrated collaboration of many disciplines to create a product-specific functional space.
A Q&A with West Pharmaceutical Services.
The most effective professionals possess a particular set of skills—five of them, to be exact. Your mastery of the five critical skills is critical to your career success.
Selecting the right actuator for use in any manufacturing operation involves a host of application-specific variables, including required stroke length, load capacity, acceleration, maximum speed, and positioning repeatability. Add a cleanroom specification to the list and the list of available options becomes smaller.
Cleanroom managers need an easier way to document, file, and quickly retrieve Quality Assurance Inspection Records, training, cleaning, and auditing records.