Quality Assurance and Control

Drug developers can't leave identification of potentially lethal organisms to...
By DuPont Qualicon
Case study
In this case study, DuPont Qualicon uses its RiboPrinter Microbial Characterization System to identify an organism in a pharmaceutical company's new asthma inhaler.

Multipoint sampling for AMC monitoring
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions explains airborne molecular contamination (AMC) and the steps needed to successfully implement an online AMC sampling and monitoring system.

Eliminating bacteria from infant formula
By DuPont Qualicon
Case study
In this case study, DuPont Qualicon helps a European company isolate a microbe that was consistently contaminating batches of infant formula at three of its factories.

Key tests for breakthrough blood safety system
By MDS Pharma Services
Case study
In this case study, MDS Pharma Services performs viral validations for Navigant Biotechnologies that help the company perfect the system, obtain Food and Drug Administration approval and move the product to market.

Quality Control Testing
By Azopharma Inc.
Product collateral
Azopharma Services offers quality control testing for Active Pharmaceutical Ingredients, pharmaceutical intermediates, excipients, and finished products. Azopharma uses a wide range of analytical techniques from physical testing to complicated chromatographic techniques.

Pharmaceutical Analytical Services
By AAI Pharma Inc.
Product collateral
AAI Pharma's pharmaceutical analytical services provide more than just testing, but are in accordance with regulatory compliance, using modern methods and SOPs in all areas: from raw material and active ingredient testing to stability and compendial testing.

Quality Control/Quality Assurance
By AAI Pharma Inc.
Product collateral
AAIPharma has compiled a history of successful GMP, GLP, GCP audits and Pre-Approval Inspections (PAIs).

AAIPharma Services Offerings
By AAI Pharma Inc.
Product literature
AAIPharma is a provider of product development and support services to the pharmaceutical, biotechnology, and medical device industries. They offer a range of services including analytical, bioanalytical, clinical, and pharmaceutical services.

Requesting methods validation for abbreviated new drug applications
By FDA Center for Drug Evaluation and Research
White paper
This white paper by the FDA's Center for Drug Evaluation and Research (CDER) describes situations in which review chemists should submit abbreviated new drug applications (ANDAs).

Quality control of TOC measurements
By GE Analytical Instruments
Application note
This application note by GE Analytical Instruments offers insights into the use of its total organic carbon (TOC) analyzers including calibration, verification, system suitability and the use of laboratory control samples.

Drug developers can't leave identification of potentially lethal organisms to...
By DuPont Qualicon
Case study
In this case study, DuPont Qualicon uses its RiboPrinter Microbial Characterization System to identify an organism in a pharmaceutical company's new asthma inhaler.

Multipoint sampling for AMC monitoring
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions explains airborne molecular contamination (AMC) and the steps needed to successfully implement an online AMC sampling and monitoring system.

What's in a name? Using definitive DNA typing
By DuPont Qualicon
Case study
In this case study, DuPont Qualicon uses its RiboPrinter microbial characterization to definitively identify a wide range of bacteria.

Advances in large-scale biopharmaceutical manufacturing and scale-up production
By ASM Press
White paper
This white paper by American Society for Microbiology Press provides a unique, unbiased view of the current state of the science and technology associated with biopharmaceutical manufacturing and scale-up production.

HIAC 9705 Liquid Particle Counting System
By Hach Ultra
Product collateral
The HIAC 9705 liquid particle sampling system technology provides consistent dispersion and highly pure sampling, thereby achieving accuracy and efficiency in the analysis of injectables, precision cleaning, parenteral particle counting and verification of WFI / PW / DI waters per USP testing guidelines.

The Aqueous Cleaning Handbook
By Alconox Inc.
White paper
This handbook by Alconox Inc. contains summaries of what aqueous cleaning is and how it works, alongside critical information on how to select an aqueous cleaner and make the most of the cleaning potential of an aqueous-cleaning system in many different industries.

Designing Safety into Size Reduction Equipment and Processes
By Fitzpatrick Co.
White paper
This white paper by Fitzpatrick Co. addresses the historical approach to safety requirements in pharmaceutical manufacturing during the size reduction process, containment techniques, the European initiative known as Atex and clean-in-place systems.

Effective heat sterilization in CO2 incubators
By Thermo Electron Corp.
White paper
This white paper by Thermo Electron Corp. describes the heat sterilization cycle, which eliminates vegetative microorganisms and persistent fungal spores.

Newform Cleanstream Bag and Cleansteam Easy-Tear Bag
By ATMI Packaging Inc.
Product collateral
Striving to meet the need for ultraclean, sterile packaging, ATMI Packaging has developed the Cleansteam Bag using DuPont’s FDA-approved uncoated Tyvek combined with HDPE.

Laboratory Glassware Washers and Dryers
By Hotpack
Product collateral
Hotpack glassware washers feature baskets and racks that allow thorough cleaning of the entire range of uniquely shaped vessels used in modern research.

Carbon analysis for cleaning validation
By Anatel Corp.
Application note
In this application note, Anatel Corp. describes how the cleaning of drug manufacturing equipment is validated and explains the methodology used with linearity graphs.

Environmental testing and monitoring: Deciphering compliance requirements for...
By Microtest Laboratories
White paper
This paper reviews the key elements of a best-practice environmental testing program for pharmaceutical and medical device manufacturers, including sterilization standards, FDA requirements, and the critical factors in maintaining controlled environments.