Life Sciences
Extrapolate To Production: Quality and Economics
By Barbara Kanegsberg, Ed Kanegsberg
Let us assume there is a promising prototype for a critical product, a prototype for which we have reached the “ah-ha” moment.
When Worlds Don't Collide--But Ought To
By Barbara Kanegsberg, Ed Kanegsberg
Pharmaceutical and medical device manufacturers tend to operate in separate worlds.
Key Considerations For Cleanroom Conveyors
By Mark Dinges
The case for modular conveyors
Creating A Sterile Link Between Stainless and Single-Use Bioprocessing Systems
By John Boehm
Today’s bioprocessing and pharmaceutical manufacturers are facing some of the most challenging market conditions ever. The U.S. Food and Drug Administration and other regulatory agencies expect manufacturers to develop robust processes and incorporate strong risk-management programs.
Drug Reconstitution: Market Needs and Technical Challenges
By Graham Reynolds
Many reconstituted drugs are administered at home by the patient. Different technologies for reconstitution have gained approval and acceptance among pharmaceutical companies and their patients.
The Importance of Leachables And Extractables Testing For A Successful Product Launch
By Frances L. Degrazio
The FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics, addresses the review and evaluation of packaging requirements.
Sorbent Solutions Ensure Moisture Management and Product Stability
By Adrian Possumato
Sorbents represent a class of active packaging components that can be used to guard against the effects of degradation, ensuring the integrity of packaged pharmaceuticals and other environmentally sensitive products. The author answers some common questions and discusses the benefits of active packaging to ensure product stability.
Challenges in Pharmaceutical Packaging: A Q&A with Fran DeGrazio
By Paul Nesdore
While the uninformed may think that once the product rolls off the assembly line to be packaged,we need no longer worry, that’s far from the case.
How To Minimize Contamination When Transferring Items Into Hospital Cleanrooms
By Suzanne Stubbs
This article will look at ways to reduce the initial bioburden on items passed into the cleanroom, so that contamination is minimized.
Managing Product and Environmental Microorganisms In Your Facility
By Gregg Mosley
A view of the ongoing effort, means and challenges, detecting, identifying, and controlling bioburden in laboratories, pharmaceutical and medical device manufacturing, and the environment.
Five Things To Look For In A Medical Packaging Vendor
By Steve Mclaughlin
There are numerous factors to consider in packaging; some obvious, some not so obvious.
Building An Efficient Sterile Pharmaceutical Packaging Line - What You Need To Know
By Nicole Zampino
Many factors must be considered in handling an automated packaging system ranging from meeting FDA requirements to speed and consistency.
A Case Study in Clean Room Packaging Development
By Brian Ivey
It is always interesting to share strategies in packaging development with others in the clean room industry. A common theme in discussions I have had over the years is the challenge packaging engineers face developing the best product for a particular application.
Medical Device Manufacturers Extend Quality Control, Regulatory Conformity through Customer Relationship Management Sofware
By Dena Solt
While quality control is essential for any manufacturing company, it is a life and death issue for manufacturers of medical devices. Heavy regulatory requirements force these companies to comply with ; standards for safety, effectiveness, identity, strength and quality.
Understanding Clean Packaging
By Brian Ivey
I receive calls every day that start with sentences like, "I need a clean pouch." As I ask a series of questions that will help me understand the needs of this potential customer, I can feel a growing impatience at the other end of the phone. You can almost sense the caller thinking, "I just want a clean bag for gods sake, quit asking questions." But the questions need to be asked, because, "clean packaging" is a relative term.
Determining Particle Count in Clean Packaging Film
By John F. Stuerzel
Given the lack of up-to-date standards and the importance of optimizing communication between vendors and users, the contamination control industry needs a universal procedure for the testing of clean film packaging. This article provides concise, definitive directions for doing that.