By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
This year's Pack Expo was held at the Las Vegas Convention Center from September 23 to 25, and with so many experts from the pharmaceutical industry planning to attend, my expectations for the show were high. After finishing preparations for interviews, visits, press conferences, and plenty more that the show had to offer, I took off for Sin City with a packed schedule in one hand and gambling money in the other.
By Hemi Sagi, Director, ATC, Inc.
Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak tightness design specifications. As product leakage is typically a microflow phenomenon, there are difficulties in applying relevant tools for testing, correlating, and analyzing leak tightness during product manufacturing and quality control.
By Malcolm McLaughlin, Alconox, Inc.
The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous. Virtually any pharmaceutical manufacturing equipment, from tablet press to a stainless-steel mixing tank, can achieve their defined critically clean criteria using aqueous cleaning. Typically, aqueous cleaners are formulated to ensure maximal cleaning performance by using key ingredients, such as surface active agents (surfactants), that are excellent wetting agents allowing the cleaning solution to penetrate into crevices while getting under soils to allow for removal. Often, very dilute solutions of aqueous cleaner effectively removes even worst-case substances off a variety of hard surfaces, including stainless steel, glass, plastic, or porcelain.
By Jane Metcalfe BSc (Hons), MSc, Field Applications Specialist, Bioquell UK Ltd
This white paper focuses on the challenges facing modern oncology pharmacies concerning the aseptic preparation of cytotoxic drug compounds. It considers the current regulatory and health and safety issues faced by pharmacists, and details some of the measures to tackle these problems, such as the use of isolator technology and the application of good manufacturing practice and quality risk management principles.
By Bob Applequist, Labconco Product Manager
Water purity supplied to a laboratory glassware washer for rinsing has been the subject of debate in regards to the end result of producing clean glassware. It should be noted that the term ‘deionized water’ does not reference any specific water purity level. The deionization of water produces water within a wide range of purity levels. The deionization process can be used to make medium-grade water at 10 to 20 microsiemens of conductivity, or, it can be used in polishing systems to produce water with a 16 to 18 megohm resistivity level.
By Bill Swisher, Director of Business Development, Ultriva Inc.
Lean manufacturing has become the de facto best practice across most manufacturing companies. Companies that have embraced Lean principles have reduced their lead times, improved quality, lowered inventory, and engaged their employees.
By Andre Petric, President, Kraemer USA
There are a number of things to consider when integrating a deduster into your manufacturing line. Before contacting a supplier, be sure to assess your needs by gathering the following four pieces of data.
By Eduardo Jule, Ph.D., Senior Manager, Formulation and Pharmaceutical Development
Formulation scientists have become pivotal to pharmaceutical development, in that they are often faced with the daunting challenge of not only identifying the most suitable drug delivery platform among a myriad of options, but also developing and validating robust systems that address the challenges posed by increasingly complex drug candidates, in ever-shortening time frames.
Counterfeit Drugs: Serialization, Track And Trace #300 Level: Beginner (1-5 years industry experience); Date: Thursday, October 10, 11:15 am - 12:15 pm; Speakers: Mike Salinas and Victor Diaz
Packaging equipment suppliers and life science manufacturers alike are playing "Beat the Clock" to comply with California's e-pedigree requirements for prescription drugs. Highlighted are some of the not so obvious strategies and nuances for successful implementation of serialization track and trace at the saleable unit level for a new packaging line from a project management perspective.