Articles by Jerold Martin - Pharmaceutical Technology

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Articles by Jerold Martin

Pre-use Filter-Integrity Testing: To Test or Not To Test?

There is no harmonised guidance on pre-use integrity testing of sterilising filters, prompting discussion among users as to whether such testing is necessary.
Sep 1, 2012

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Understanding Gamma Sterilisation

Single-use systems used for the production of culture media and the filling of sterile APIs and drug products must be sterilised prior to use. This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators to support a sterile API, drug product or vaccine application.
Feb 1, 2012

This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators.

The Impact Of Single-Use Systems

Jerold Martin, senior vice president global technical affairs, at Pall Life Sciences, explains the importance and impact of single-use systems in sterile environments.
Dec 1, 2011

Jerold Martin, senior vice president global technical affairs, at Pall Life Sciences, explains the importance and impact of single-use systems in sterile environments.

Focus on Standardisation, Quality by Design and Regulatory GMP

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.
Nov 1, 2011

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Particulate Quality Of Single-Use Filling Systems

Sep 1, 2011

Strategies to minimise particle levels in the finished product when using single-use technologies downstream of final filters.

The Single-Use Technology World Tour

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.
Jun 1, 2011

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.

Trends Towards Standardisation

Feb 11, 2011

Over the past 10 years or so, we've seen single-use technologies explode from production-scale filter capsules, tubing and simple biocontainers to encompass sterile connectors, membrane chromatography adsorbers, bioreactors, mixers, and integrated platform systems with increasing levels of sensors and automated controls.

Developing A Quality Agreement Template For Single-Use Systems

Oct 1, 2010

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.

Aseptic challenges: the experts' view

Leading pharmaceutical experts talk to Pharmaceutical Technology Europe about trends and challenges in aseptic techniques and technologies.
Dec 1, 2009

What have been the key innovations that have shaped current aseptic practices and techniques?

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