White Papers/Application Notes

Changes in ISO 14644-1 to Improve Confidence in Quality for Critical Life-science Applications
Thursday, May 10, 2012
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness is under revision as part of the normal ISO periodic review cycle. An international working ... read more
The Benefits of Using AAIPharma Services for Elemental Impurity Analysis Using ICP-MS Technology
Thursday, May 10, 2012
Metal impurities have historically been monitored in drug articles intended for use by humans and animals. Drug articles include active pharmaceutical ingredients (API), excipients, drug products and ... read more
AccuPRO-ID® - Bacterial Identification Using MALDI-TOF Technology
Friday, April 20, 2012
Accurate classification of unknown bacterial isolates is an essential first step in understanding the impact these organisms have on an environmental monitoring program. Accugenix offers various ... read more
Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations
Friday, April 20, 2012
A thorough evaluation process for microbial identification systems should consist of both a technical and financial review, regardless if you are performing internal testing and outsourcing. All ... read more
Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count
Thursday, March 22, 2012
Currently available growth-based rapid microbiological methods (RMM) provide either a quantitative cell count, estimation of viable cell concentration, information regarding the presence of a ... read more
The NanoRam Hand-held Raman Spectrometer
Wednesday, March 21, 2012
In recent years, Raman Spectroscopy has gained a reputation in market segments that require the rapid identification of unknown compounds, such as the testing of chemicals, measurement of ... read more
Determination of Counterfeit Drugs
Monday, March 05, 2012
Counterfeit drugs are a substantial and growing problem, both in the developed and in the developing world. read more
Content Uniformity on Tablets
Monday, March 05, 2012
New regulations make in-process testing more popular to demonstrate adequacy of mix (cGMP) and for the content uniformity of finished dosage forms. read more
Monitoring a Process Critical Control Parameter for Crystallization
Monday, March 05, 2012
Crystallization is an important step in the manufacture of pharmaceutical ingredients. read more
In-Line Solvent Recovery Using FT-NIR
Monday, March 05, 2012
The solvent recovery process involves the distillation of a “feed” or “crude” solvent from a low purity (e.g. 60%) to a pure product that can be re-used in the manufacturing process. read more
Monitoring the Water Content in Heat Transfer Fluid
Monday, March 05, 2012
Manufacturing processes often require reaction temperatures to be tightly controlled and/or varied during the course of the reaction. read more
Filter Drier Endpoint Analysis using FT-NIR Specstroscopy
Monday, March 05, 2012
Modern process analytical technologies (PAT) in pharmaceutical production and quality control is helping to move industry to a new level of productivity. read more
On-line Analysis of Tablets Including Content Uniformity
Monday, March 05, 2012
FDA’s PAT initiative requires pharmaceutical manufacturers to improve the critical quality performance monitoring for ensuring final product quality. read more
Powder Moisture Analysis Using FT-NIR
Monday, March 05, 2012
Controlling the production process and using quick and reliable methods of quality control can help to improve product quality. read more
In-Line Reaction Monitoring
Monday, March 05, 2012
Real-time monitoring of chemical reactions compared with sample-based monitoring provides very real benefits to a manufacturing process. read more

Changes in ISO 14644-1 to Improve Confidence in Quality for Critical Life-science Applications

The Benefits of Using AAIPharma Services for Elemental Impurity Analysis Using ICP-MS Technology

AccuPRO-ID® - Bacterial Identification Using MALDI-TOF Technology

Evaluating Library Databases for Microbial Identification: Critical Aspects and Recommendations

Case Study of a New Growth-Based Rapid Microbiological Method (RMM) That Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count

The NanoRam Hand-held Raman Spectrometer

Determination of Counterfeit Drugs

Content Uniformity on Tablets

Monitoring a Process Critical Control Parameter for Crystallization

In-Line Solvent Recovery Using FT-NIR

Monitoring the Water Content in Heat Transfer Fluid

Filter Drier Endpoint Analysis using FT-NIR Specstroscopy

On-line Analysis of Tablets Including Content Uniformity

Powder Moisture Analysis Using FT-NIR

In-Line Reaction Monitoring

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