Newsletter | December 17, 2013

12.17.13 -- Understanding Test And Measurement Equipment Performance In The Laboratory

Pharmaceutical Online Newsletter
Manufacturing Critical Environments Logistics
Inspection Packaging QA/QC
A 15-Minute Guide To Compliant Document Management For Life Sciences
Life Sciences quality and manufacturing organizations face three critical industry forces: increasingly stringent regulation; globalization; and virtualization of supply networks.
» From The Editor
Understanding Test And Measurement Equipment Performance In The Laboratory
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Any good quality manager knows that assumptions about an instrument can lead to unpleasant surprises during the calibration cycle. Test and measurement equipment play a critical role in most production and development processes. These instruments are used to make decisions regarding the effectiveness of processes and to ensure product quality.

cGMP Compliance: Top Trends To Know For 2014
Date: Wednesday, January 22, 2014 • Time: 1pm – 2:30pm EST

FDA GMP Inspections: Proven Preparation And Survival Techniques
Date: Thursday, January 30, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Manufacturing
The Financial Advantages Of Purchasing Used Equipment And Investment Recovery Services
By Matt Hicks, COO, Federal Equipment Company
The loss of a patent for a branded drug product leads to opportunities for generic-biopharmaceutical manufacturers. Once a blockbuster drug reaches the end of its branded life cycle, generic manufacturers will gear up to produce lower-margin "copies."
WHITE PAPER: Probiotics In Pharmaceuticals: Friendly Bacteria
By Kevin Ward, Biopharma Technology Limited
Probiotic bacteria have long been used in probiotic yogurt drinks or provided in tablet form. People have often taken these 'friendly' bacteria to help boost their own systems’ internal flora and fauna; friendly bacteria can help protect our immune system and aid digestion. Bacteria have been known to survive a variety of conditions; however, storage in yogurt drinks or tablet form is often not enough.
WHITE PAPER: A Guide To Effectively Sourcing And Purchasing Liquid Filling Systems
By Robert Rosen, Filamatic
There are a few questions to ask yourself when determining which liquid filling machine is right for your project. As each machine is unique in its filling techniques and performance abilities, certain questions that are asked will help to narrow down the choices and to select a machine that will best suit your application.
APPLICATION NOTE: Determining Particle Size Distribution: Important Milling And Micronization Factors
BROCHURE: DV2T Viscometer: Fast And Easy Viscosity Measurements
BROCHURE: Continuous Tablet Manufacturing
PRODUCT: Large Volume Evaporator: Rocket
» Critical Environments
WHITE PAPER: Water Purity And Lab Glassware Washers: Just How "Pure" Does It Have To Be?
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.
WHITE PAPER: Flexible Measuring And Control In Reverse Osmosis Systems
By Christof Kundel, Segment Manager Water Treatment, Bürkert Fluid Control Systems
Reverse osmosis systems play a central part in water treatment. In industrial applications, for example, reverse osmosis is used for purifying process water, producing drinking water, and desalinizing seawater as well as for producing ultra pure or pharmaceutical water. In addition to these processes that aim at reducing the concentration of the substances dissolved in the water, the beverage industry also uses reverse osmosis systems for increasing concentrations, e.g. in the manufacture of fruit juice concentrates or for concentrating the must in wine production.
APPLICATION NOTE: Instantaneous Microbial Detection Defined
DATASHEET: Hydrogen Peroxide Vapor (HPV) Biodecontamination Walk-In Chamber
By Bioquell Inc.
PRODUCT: Small Hazardous Materials Containers
» Logistics
ARTICLE: How To Map Environmentally Controlled Chambers: An 8-Step Guide
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
"Please tell me how to map this chamber!" This is a plea we hear at every Vaisala Good Manufacturing Practice seminar. The question deals with environmentally-controlled chambers, everything from small refrigerators or freezers to walk-in chambers, or even large warehouses regulated under cGMP guidelines. Attendees who ask the question are usually interested in how to map a chamber for maximum reliability or effectiveness, as opposed to meeting the U.S. Food and Drug Administration (FDA) regulations.
WHITE PAPER: How To Classify Biological Specimens For Transport
By Michael Gotz, Director of Dangerous Goods Quick Group of Companies
Transportation of biological substances and infectious materials has become increasingly challenging. Understanding the dangerous goods classification requirements is critical to ensure that your shipments are in compliance with the law.
CASE STUDY: Marken Overcomes A Snow Emergency To Deliver Lifesaving Drug
PRODUCT/SERVICE: Bio-STAR Technology: Clinical Trial Logistics Management
PRODUCT: Cargo Companion Tracking Solution
» Inspection
WHITE PAPER: Tablet Dedusting: Which Method Fits Your Process?
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.
DATASHEET: High-Speed Checkweighers: CW3 6000M
BROCHURE: Package Integrity Inspection System: Veripac Series
PRODUCT: NextGuard X-Ray Inspection Systems For Food And Pharmaceutical Applications
PRODUCT: Portable Tabletop Inspection Hood
» Packaging
ARTICLE: Serialization Strategy 101
By David A. Loy, Senior Director of Quality and Regulatory Affairs, Aphena Pharma Solutions
With every recurrence of confirmed counterfeit drug product in the pharmaceutical supply chain, the pressure increases to establish a national standard for pharmaceutical track-and-trace solutions. Although a universal standard has yet to emerge, there is one set of requirements that is currently driving action: the California Board of Pharmacy's ePedigree.
DATASHEET: In-Line Leak-Testing Machine For Stick Packs: SQZ
By Bonfiglioli Engineering SPA
DATASHEET: Greenbox Reusable Thermal Packaging
By ThermoSafe, Sonoco Protective Solutions
BROCHURE: Thermal Desorption Inlet System: Model 3250
PRODUCT: Pharmaceutical Capsule Filling
APPLICATION NOTE: The Sizing Of Nonspherical, Submicron Particles Using Polarization Intensity Differential Scattering (PIDS)
WHITE PAPER: 21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?
WHITE PAPER: 10 Steps For Optimizing Valve Terminals
WHITE PAPER: Rupture Test: A Quick And Easy Way To Avoid Soft Gel Capsule Failure
BROCHURE: cGMP Radiosynthesis: Will Your CRO Be There When It Counts?
Europe's Largest Gathering Of The Cool Chain And Temperature Controlled Logistics Community
Every year, 450+ logistics, supply chain and quality assurance leaders meet to discuss the future of the temp controlled logistics industry. This coming year there's a lot to discuss... With the GDP guidelines finally in effect, building or rebuilding your ambient supply chain in a cost-effective/compliant way is top of the agenda.
Follow Pharmaceutical Online:
LinkedIn    Twitter    YouTube