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SCIENTIFIC IMAGE CREDIT: US National Institute of Standards and Technology (US NIST) /Colorized Micrograph of a Microrotor
Learn from the experience of other scientists and laboratory personnel and share scientific and laboratory resources such as Tips, Case Studies, Articles, Templates, Questions and Answers, Manuals, Reports, Abstracts, Podcasts, Presentations, Procedures, Videos, Posters, Checklists and Reviews in our Expert Exchanges ! If you have any questions, please contact Contract Laboratory .com at 1-403-770-1992 or email us.
Scientific, Technical and Laboratory Expert Exchanges
Submitter Title
Oxidative Stress Assessment at Kronos Science Laboratory - Oxidative Stress Assessment at Kronos Science Laboratory
by
Christopher B. Heward, Ph.D. and Yali Su, Ph.D.

In recent years, research evidence has been accumulating that damage to cell components (proteins, cell membrane lipids, and the DNA of both chromosomes and mitochondria) by oxygen free radicals (also known as Oxidative Stress Assessment at Kronos Science Laboratory
Submitter: Kronos Science Laboratory
Extensional Rheometry - CPG has expertise in extensional rheometry, which is the study of fluid flow in an extensional, rather than shear, deformation. The bulk of material processing involves a combination of shear and extension, and the flow resistance of polymeric materials can change dramatically with extensional deformation. This article summarizes a simple approach for extensional rheometric characterization. read more... Extensional Rheometry
Submitter: Cambridge Polymer Group inc
Bringing medicinal products to market in The European Union (EU) - Bringing Medicinal Products to the European Union Market
By Dr. Jan van der Weide
Pharmalink Consulting Ltd.

Introduction to the European Union

The European Union (EU) is a supranational and intergovernmental union of twenty-seven states in a category of its own. It was established in 1992 by the Treaty on European Union (The Maastricht Treaty), and is the de facto successor to the six-member European Economic Community founded in 1957. Since then new accessions have raised its number of read more... Bringing medicinal products to market in The European Union (EU)
Submitter: Pharmalink Consulting Inc
HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations - HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations

Dr Jung Wing Wan, Pharmalink Consulting Inc.

Dr Jung Wing Wan of Pharmalink Consulting Ltd ponders the quality, safety and efficacy considerations of herbal products, and examines the development of regulations inside and outside Europe.

Information about the author.
Dr Jung Wing Wan is currently a regulatory project manager for Pharmalink Consulting Inc., having worked on a number of European regulatory projects wi read more... HERBAL MEDICINAL PRODUCTS: Quality, Safety and Efficacy considerations
Submitter: Pharmalink Consulting Inc
"Future Trends of the GMP's in Japan - based on ICH Guidelines and related activities",
Submitter: Expert Validation Consulting, Inc.
A Practical Guide to Applying Impact and Risk Concepts to - INTRODUCTION

In recent years, the Food and Drug Administration (FDA)-regulated industry has been listening to agency representatives and consultants talking about the need to implement a risk-based approach to decision-making processes.  I totally agree with the need to implement this A Practical Guide to Applying Impact and Risk Concepts to
Submitter: Expert Validation Consulting, Inc.
RECENT FDA AND INTERNATIONAL REGULATORY EFFORTS AFFECTING FACILITY AND UTILITY SYSTEMS DESIGN AND QUALIFICATION - Introduction		 

It is clearly recognized that the use of adequate facilities and utility systems has a critical effect on our capacity to produce products, which will consistently meet the pre-defined specifications.  The adequate design of such facilities and ancillary systems is vital to the overall success of any manufacturing process/operation. 

The harmonization of the compliance requirements established by regulatory agencies around our global industry is an on-going reality. It will read more... RECENT FDA AND INTERNATIONAL REGULATORY EFFORTS AFFECTING FACILITY AND UTILITY SYSTEMS DESIGN AND QUALIFICATION
Submitter: Expert Validation Consulting, Inc.
Top 10 Tips for Safely Handling and Using Gas Cylinders  - Not every one needs to know that fluorine will violently ignite many substances, that silane burns on contact with air, or that ammonia will decompose thermally into twice its volume. But if you work with specialty gases, this information is essential. Safety must always be a primary goal when working with specialty gases -safety and knowledge go hand-in-hand. 

To improve your chances of preventing hazardous accidents, follow these Top 10 Tips for safely handling and using gas cylinders:  

 read more... Top 10 Tips for Safely Handling and Using Gas Cylinders
Submitter: A. Cafferty, Scott Gas
Concordance of MBL Protein Concentrations, Functional Activities and Genotypes in a Healthy Control Population  - http://www.ibtreflab.com/library/PDF/2005AAAAIPosterMBL.PDF read more... Concordance of MBL Protein Concentrations, Functional Activities and Genotypes in a Healthy Control Population
Submitter: IBT Reference Laboratory
Abstract Presented at the 5th Meeting of the European Society for Chlamydial Research  - http://www.ibtreflab.com/library/PDF/EuropeanCPNConference2004.PDF read more... Abstract Presented at the 5th Meeting of the European Society for Chlamydial Research
Submitter: IBT Reference Laboratory
Are Chlamydia pneumoniae and Mycoplasma pneumoniae Important Etiological Agents of Respiratory Tract Infection in a Family Practice Setting?  - http://www.ibtreflab.com/library/PDF/2004AAAAIPoster.PDF read more... Are Chlamydia pneumoniae and Mycoplasma pneumoniae Important Etiological Agents of Respiratory Tract Infection in a Family Practice Setting?
Submitter: IBT Reference Laboratory
Preventing specimen degradation - Many clinical samples can deteriorate during shipment and storage, due to storage at improper time and temperature.  CliniSense is introducing a new electronic chip technology, called the Preventing specimen degradation
Submitter: Stephen Zweig, Clinisense
New Approaches for Assessing Conditioning and Quantifying Silicone Deposition on Hair - In this technical paper, Dow Corning scientists present results from deposition evaluations and analytical studies that show promise for the creation of hair care products. read more... New Approaches for Assessing Conditioning and Quantifying Silicone Deposition on Hair
Submitter: STERIS Isomedix Services
An Analytical Method for Adsorbed Soil Gas Hydrocarbons (SGH) to Depict Anomaly Patterns over Various Types of Deeply Buried Deposits - Geochemical Actlabs & Geosoft (915 KB)
Interactive Demo - Integrating Exploration Geochemistry Application Data
A An Analytical Method for Adsorbed Soil Gas Hydrocarbons (SGH) to Depict Anomaly Patterns over Various Types of Deeply Buried Deposits
Submitter: Activation Laboratories Ltd.
STERILITY AND FUNDAMENTAL REQUIREMENTS OF STERILE PRODUCTS - What is sterility?
Sterility is the total absence of pathogens in a finished sterile product.

Sterile products include: parenterals (injectables), ophthalmics, inhalation aerosols, and their administration devices. 

One of the first steps in manufacturing a sterile product is the use of rigid aseptic procedures in a well designed controlled clean room environment. 
Clean rooms are constructed, and maintained to prevent environmental contamination during manufacture.
	Includes: 
o	smoo read more... STERILITY AND FUNDAMENTAL REQUIREMENTS OF STERILE PRODUCTS
Submitter: Dr. Janice Cacace, p Formulate
LTQ FT MS Review - JCL Bioassay, Inc. has recently purchased LTQ FT MS by Thermo Electron Corporation. This system can assist in toughest analytical challenges in metabolic studies, proteome analysis, pharmaceutical discovery, and all other applications demanding rigorous structural characterization.  For more information, please contact 847-866-0410.  read more... LTQ FT MS Review
Submitter: Keiji Asada , JCL Bioassay, Inc.
Solving the Universal Vulnerability and Liability Problems - NOVA WHITE PAPERS

Solving the Universal Vulnerability and Liability Problems 
of Public Water Systems

Paul J. Pearce, PhD
 
Dear Reader:

In the homeland security era, public water systems face an entirely new set of vulnerability and liability problems. 

A new class of services and products may be the solution to these problems.

In compliance with the Bioterrorism Act of 2002 (Public Law 107-188), many public water systems have completed their vulnerability assessments (VAs). A read more... Solving the Universal Vulnerability and Liability Problems
Submitter: Nova Biologicals, Inc.
Quality Organizations Provide for a Unique Learning Experience - By Farrah N. Khan, CQA, RQAP-GLP
Northview Pacific Laboratories' Quality Assurance Department is taking an active role with several quality organizations. New systems, processes and ideas are always being introduced in the world of quality and it isn't an easy task to keep on top of all of them. One way that Northview keeps on track is to stress the importance of continued education. 
Our QA staff are not only members, but active participants in quality organizations such as:

American Socie read more... Quality Organizations Provide for a Unique Learning Experience
Submitter: Northview Pacific Laboratories
Supplement 8 of USP 23 Serves As A Guide For Establishing A Microbial Monitoring Program - At BEC Labs, we are often asked to help customers define environmental sampling plans for their manufacturing facilities. In doing so, we now refer them to Supplement 8 of USP 23, Section 1116, Microbiological Evaluation of Clean Rooms and Other Controlled Environments. Following is a summary of the informational chapter, which addresses how to establish, maintain, and control the microbiological quality of a controlled environment.

Cleanrooms have traditionally been classified using air clea read more... Supplement 8 of USP 23 Serves As A Guide For Establishing A Microbial Monitoring Program
Submitter: BEC Laboratories, INC.
Method Development & Validation - A pharmaceutical company required a full set of validated analytical procedures in order to proceed through clinical trials towards FDA approval. Chemir Analytical Services developed and validated chromatographic methods to assess the quality of the materials, including determination of physical properties and levels of impurities. The detailed report was satisfactory for FDA review.
 read more... Method Development & Validation
Submitter: Chemir Analytical Services
New-age Paint Thickening & Rheological Additives : Solvitex & Solvizen
Submitter: Mr. R. S. Subramanium
Using Contract Services Wisely: - Contract services are a means to boost your productivity and capabilities without adding permanent capabilities. Finding the right outsourcing partner should reward you with a strategic alliance for your business. Finding the wrong partner will slow your progress and prevent you from reaching your potential. 

A couple of simple questions will move you on your way to finding a laboratory that supplements your efforts to develop a product, maintain quality, understand the chemistry, or accelera read more... Using Contract Services Wisely:
Submitter: Alliance Technologies, LLC
Contract Pharma Annual Meeting Review
Submitter: Raymundo Sison
Labeling of Laboratory Solutions
Submitter: Global Regulatory
Improving your Lab Resume
Submitter: GMP Audit
Auditing
Submitter: GMP audit
Writing SOPs
Submitter: Global Regulatory
Laboratory Data Errors and Corrections - If your lab, or your customers' samples, are regulated by the Food and Drug Administration (FDA), do not obscure or erase original laboratory data entries when making corrections.  Instead, place one single line through the incorrect information, write the new information, date the correction, and initial or sign your name by the correction. You must also provide an explanation for why the correction was necessary. The explanation will make it easier for you to remember and describe the actual s read more... Laboratory Data Errors and Corrections
Submitter: Global Regulatory
Recording of Laboratory Data
Submitter: GMP Audit
Passwords for Computerized Instruments - If your firm is regulated by the FDA, develop an operating procedure (SOP) for assigning, changing, and choosing passwords for computer systems. Check the computer validation guidelines available at www.FDA.gov for information on controlling entry to and use of computerized instruments. read more... Passwords for Computerized Instruments
Submitter: Global Regulatory
Quality Agreements and Quality Contracts - If your firm is regulated by the FDA, develop Quality Agreements or Quality Contracts with your contract laboratories. read more... Quality Agreements and Quality Contracts
Submitter: Global Regulatory
URINARY EXCRETION OF THREE NUCLEIC ACID OXIDATION ADDUCTS  AND ISOPROSTANE F2a MEASURED BY LIQUID CHROMATOGRAPHY MASS    SPECTROMETRY IN SMOKERS, EX-SMOKERS, AND NONSMOKERS             - Abstract-Quantification of 8-iso-prostaglandin F2a (8-iso-PGF2a) has been suggested to be a reliable indicator of lipid peroxidation that may be related to in vivo free radical generation, oxidative damage, and antioxidant deficiency. We have developed a LC-MS/MS method to quantify 8-iso- PGF2a and its dinor metabolite, 2,3-dinor-8-iso-prostaglandin F2a (2,3-dinor-8-iso-PGF2a), in human urine samples. After an initial purification step using an automated C18 solid phase extraction procedure, the read more... URINARY EXCRETION OF THREE NUCLEIC ACID OXIDATION ADDUCTS AND ISOPROSTANE F2a MEASURED BY LIQUID CHROMATOGRAPHY MASS SPECTROMETRY IN SMOKERS, EX-SMOKERS, AND NONSMOKERS
Submitter: Kronos Science
Polymer Materials Selection for Radiation-Sterilized Products - Choosing the right polymer for a radiation-sterilized device requires an understanding of radiation effects, manufacturing processes, and the product's intended use. read more... Polymer Materials Selection for Radiation-Sterilized Products
Submitter: STERIS Isomedix Services

Submitter:
Laboratory Notebooks
Submitter: Global Regulatory
FDA Inspections
Submitter: Global Regulatory
Selecting a Contract Laboratory
Submitter: Global Regulatory
Effective Use of Contract Laboratories
Submitter: Global Regulatory
Cosmetics & Toiletries - Global Outsourcing & Private Label Manufacturing
Submitter: Rasik Botadra
Kronos Science Laboratory Fatty Acid Poster - Kronos Science Laboratory Fatty Acid Poster
http://www.contractlaboratory.com/www/labuploads/Kronos_ Fatty_Acid_Poster.pdf read more... Kronos Science Laboratory Fatty Acid Poster
Submitter: Kronos Science Laboratory
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