By Robert G. McGregor, General Manager, Brookfield Engineering
Capsule integrity is a given for established manufacturers with impeccable reputations. Consumers, however, know from experience that not all capsules are made equal. Some can be difficult to extract from the blister pack. Others may have gel caps with cracks, or, even worse, ruptures that allow the ingredients to spill out. Is this a manufacturing problem? Or has R&D neglected to implement a fool-proof test methodology for evaluating capsule stability? Compression and tension testing offer a technical approach with quantifiable results that can be used to assess capsule performance.
By Vinnie Hebert, Product Manager - Powder Flow Tester, Brookfield Engineering
Powder handling and processing in gravity feed systems have one basic requirement: knowledge of your powder's flow properties. Too often, this simple requirement is lacking, thereby causing manufacturing downtime due to jamming of feeder systems, arching, and rat holing. To solve or minimize these types of issues, flow aids are often used. However, a determination of how much (or how little) to use is the challenge.
By Sharon Nowak, K-Tron
The combination of twin-screw extruders and loss-in-weight feeding and pneumatic refill systems is quickly becoming the manufacturing process of choice when developing pharmaceutical solid dosage forms.
By Alex Verayo, Terra Universal
As cleanrooms grow in size and sophistication, energy demands go up significantly. Even worse, 24/7/365 operation puts substantial particulate loads on filters, increasing maintenance costs and possibly causing unpredictable — and expensive — cleanroom maintenance shutdowns.
By Bob Applequist, Product Manager, Labconco Corp.
During the past two decades in the United States there has been an increased usage of gloveboxes for a growing number of applications. Scientists, engineers, manufacturers, and facility managers have started using new terms for these devices in an effort to better define and categorize specific glovebox applications. The terms isolator, isolator glovebox, glovebox isolator, and barrier isolator are now commonly used to describe a glovebox and its functions. Unfortunately, expedient terminology usually falls short of defining the operational requirements for any specific glovebox.
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
By Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.
When I served in the military there was a term used that is still pretty familiar today: "Sound general quarters!" When this order was issued, everyone instinctively stopped what they were doing and manned whatever station was theirs during that time. All commands during general quarters came from the war room behind the bridge of the vessel.
By Wayne Garafola, Sartorius Stedim North America, Inc.
Integrity testing is a nondestructive physical test to determine the presence of over-sized pores or other defects that may compromise a given filter's retention capability. Performing filter integrity tests is a requirement by regulatory agencies (FDA, EU) when a product is labeled 'sterile'.