Life Sciences
Validation Readiness, Part 2
By Barbara Kanegsberg, Ed Kanegsberg
Planning and pre-testing are keys to successful validation.
Peristaltic Aseptic Filling Machines With a Single Use Production Philosophy
By Peter Lambert
Traditionally, fill/finish lines have used piston pumps but, in today's production environment, piston pumps suffer from a number of drawbacks.
When Worlds Don't Collide--But Ought To
By Barbara Kanegsberg, Ed Kanegsberg
Pharmaceutical and medical device manufacturers tend to operate in separate worlds.
Standardized Cleaning Approach For A New Pharmaceutical Compound
By J-M. Cardot, E. Beyssac
In the past, cleaning or cleaning validation problems were often pointed out by the authorities. A simple and standard cleaning approach can be used in the pharmaceutical industry in absence of specific know-how in order to initiate a reflection about cleaning.
Cleaning Validation Issues For Combination Devices
By Jeff Phillips, Barbara Kanegsberg, Ed Kanegsberg
Combination devices that combine traditional device substrates with an active drug delivery system present unique regulatory and assembly challenges.
Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
By John Dobiecki, Alex Mello
This article will discuss the typical routine sampling and testing requirements associated with the aseptic processing of a biopharma-ceutical from the perspective of a contract aseptic manufacturer.
Factoring Business Continuity and Risk Management in Aseptic Product Development
By Tej Poonai, Bikash Chatterjee
We will discuss how the current FDA guidance for product development can integrate the concept of business continuity into the planning process, affording organizations the ability to lay the foundation for flexibility in the operating plan, if the situation warrants it.
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.
The Advent of Rapid Microbiological Methods: Background, Applications, and Validation
By Peter R. Ball, Loris Arbizzani,, Christopher J. Mach
RMM instruments have been on the market for a number of years, but recent developments, such as performance improvements and cost reductions in the technology, have made them more attractive than in the past.
Case Study: Improving PLC Compatibility and Function Flexibility In Aseptic Blow-Fill-Seal Machine Applications
By Jim McMahon
When original equipment manufacturer, Weiler Engineering, upgraded the drive systems on its aseptic blow-fill-seal machines, a problem with its existing controller compatibility limited the functionality of its equipment.
A New Technology For Aseptic Filling of Injectable Drugs
By Benoit Verjans, Ph.D, MBA
The aseptic filling of injectable drugs has always been very challenging for the pharmaceutical industry.
The Impact of the FDA’s Adoption of Risk Management on the Design and Qualification of Aseptic Facilities
By Tej Poonai, Bikash Chatterjee
The FDA is reinventing its approach to quality and compliance and is driving the industry in the direction of a more concrete and cohesive argument for process understanding.
Medical Devices:Critical Cleaning and Surface Quality
By Barbara Kanegsberg, Ed Kanegsberg
How can an implantable medical device be optimized? in achieving harmonious interaction of the device with the host depends on critical cleaning,surface characterization, and surface optimization.
Methods and Devices For Delivery of Ultra High Purity Steam
By Jeffrey Spiegelman
Use and generation of UHP steam has become widespread and has applications in critical processes in diverse markets.
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.
A Solution for Properly Calibrating Pressure Sensors for Pharmaceutical Plants
By Terry Troyer
The problems and challenges of calibration amidst less than ideal ambient conditions
Designing A Results-Oriented Training Program for Cleanroom Operators
By Elaine Kopis Sartain
It has been said that one person can make a difference. In an aseptic operation, the risk is that this difference will lead to a negative outcome.
Chromatography Systems: Part 1 - Chromatography Concepts
By Barbara Kanegsberg, Ed Kanegsberg
One classic text defines chromatography as the separation of components of a mixture by difference in partitioning or distribution between two phases.
Regulatory Focus
By Elaine Kopis Sartain
The new draft ìaseptic guideline,î as it is often referred to in this industry, was initially released for industry feedback in 2002 by the Food and Drug Administration (FDA) as a concept paper.
Wet Chemistry: A Material Selection Process
By Gary Difazio
Choosing the correct product for a wet chemistry application in a clean room has become complicated. One must balance the chemical resistance, physical properties of the materials, and fire resistant characteristics, to satisfy the insurance underwriters and provide a safe work environment.
A Modular Approach to Engineering Guidelines for Pharmaceutical Cleanroom Construction
By Rick Dobson
The requirement to manufacture drug products is at an all time high. With the forecast for increased demand, pharmaceutical and bio-tech companies continue to set goals for finding ways to increase product yield and to reduce overall construction schedules.
Life Sciences: Aseptic Processing vs. Clean Manufacturing for Biotech
By Timothy Mitchell
The cost of designing and constructing a manufacturing facility to produce a bulk biological active ingredient for a biotechnology-derived pharmaceutical product is becoming increasingly expensive in today’s biotech industry.