Standards
FEATURED REPORTS
WHAT'S NEW
-
The MET ONE 7000
by Hach Ultra
Product collateral
The MET ONE 7000 remote airborne particle counters provide the most accurate continuous monitoring for the aseptic and sterile pharmaceutical production environments.
-
Trace Element Analysis of Organic-Rich Samples Using Axios with Pro-Trace
by PANalytical Inc.
Application note
Axios with Pro-Trace software and standards make up a unique solution for trace analysis in a wide variety of organic-rich materials.
REPORTS BY SUBTOPIC
There are currently no reports available for this topic.
Combination products: Navigating two FDA quality systems
By Microtest Laboratories
White paper
While combination products are experiencing dramatic growth, the convergence of drugs/biologics and devices brings a host of regulatory challenges. This paper addresses the critical issues in this process, including defining the FDA’s regulatory framework, reviewing new developments in FDA thinking, and developing effective quality assurance systems.
MET ONE 3400 Series Portable Airborne Particle Counters
By Hach Ultra
Product collateral
MET ONE 3400 Series airborne particle counters offer faster sampling and simple portability for ease of use and reduced technician time. Dual hot-swappable batteries minimize downtime and, thanks to its Long Life Laser technology, the 3400 performs reliably, promoting low-cost, long-term ownership.
Industry-specific OLAP: The coming wave of data analysis
By DataLoom Solutions
White paper
DataLoom Solutions discusses the advancements in data management technology and how Industry-Specific OLAP (ISO) overcomes the limitations of datawarehousing technology.
Cleanroom requirements, certification and monitoring
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions explains the monitoring of a cleanroom to meet ISO standards and to establish compliance.
Particle monitoring in pharmaceutical cleanrooms
By Lighthouse Worldwide Solutions
Application note
In this application note, Lighthouse Worldwide Solutions describes cleanroom standards, FDA and EU guidelines and how particle monitoring in cleanrooms benefits regulatory and quality control in the production of pharmaceuticals.
Impact of changes to ISO standards on contamination control programs
By Pall Corp.
White paper
This white paper by Pall Corp. explores the impact of four revised ISO fluid power standards on contamination control programs.
SOP management as a compliance tool in FDA and ISO environments
By MasterControl Inc.
White paper
This white paper by MasterControl discusses why Standard Operating Procedures (SOPs) are more than just a tool of operation, and how an effective SOP management system can support both sustainable compliance and long-term success in the market.
Combination products: Navigating two FDA quality systems
By Microtest Laboratories
White paper
While combination products are experiencing dramatic growth, the convergence of drugs/biologics and devices brings a host of regulatory challenges. This paper addresses the critical issues in this process, including defining the FDA’s regulatory framework, reviewing new developments in FDA thinking, and developing effective quality assurance systems.
MET ONE 3400 Series Portable Airborne Particle Counters
By Hach Ultra
Product collateral
MET ONE 3400 Series airborne particle counters offer faster sampling and simple portability for ease of use and reduced technician time. Dual hot-swappable batteries minimize downtime and, thanks to its Long Life Laser technology, the 3400 performs reliably, promoting low-cost, long-term ownership.
ANATEL A643a Total Organic Carbon (TOC) Analyzer
By Hach Ultra
Product collateral
The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring and is fully compliant with pharmaceutical industry methods, such as USP<643> and <645>, EP 2.2.44 and JP XV<60>.
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).
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.
Combination products: Navigating two FDA quality systems
By Microtest Laboratories
White paper
While combination products are experiencing dramatic growth, the convergence of drugs/biologics and devices brings a host of regulatory challenges. This paper addresses the critical issues in this process, including defining the FDA’s regulatory framework, reviewing new developments in FDA thinking, and developing effective quality assurance systems.
ANATEL A643a Total Organic Carbon (TOC) Analyzer
By Hach Ultra
Product collateral
The ANATEL A643a offers reliable, robust performance in water system-critical TOC monitoring and is fully compliant with pharmaceutical industry methods, such as USP<643> and <645>, EP 2.2.44 and JP XV<60>.
Technical note: U.S. Pharmacopoeia setpoints
By Mettler-Toledo Thornton
White paper
This brief white paper, a technical note by Mettler-Toledo Thornton Inc., discusses U.S. Pharmacopoeia 645, which addresses pharmaceutical water.
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.
Particle monitoring to meet USP 797
By Particle Measuring Systems
White paper
This white paper by Particle Measuring Systems reviews the requirements for non-viable particle limits and the monitoring of areas where the product is exposed. It addresses U.S. Pharmacopeia 797, which describes procedures and requirements for compounding sterile preparations.
ANATEL TOC600 Online Total Organic Carbon Analyzer
By Hach Ultra
Product collateral
ANATEL TOC analyzers are the industry standard for purified water and ultrapure water. The ANATEL TOC600 provides online TOC analysis for a range of applications requiring USP Chapter <643> and EP Chapter 2.2.44 for TOC requirements, as well as USP Chapter <645> for conductivity measurement.
High-accuracy measurement of TOC below 5 ppb levels
By Shimadzu Scientific Instruments
Application note
This application note demonstrates how Shimadzu's TOC-VW instrument meets current regulatory demands of ultrapure applications by achieving practical quantitation below 5 ppb.
