VHP as sterilant for use in isolators?

Andrew Hopkins, senior GMP inspector, MHRA, explains the guidance around the use of vaporised hydrogen peroxide for sterilisation purposes

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Implications for packaging in new API Guidance

Recently the US Food and Drug Administration released a guide to clarify good manufacturing practice for API production ...

Gearing up for Cleanroom Technology Conference 2018

Attendance to the Cleanroom Technology Conference 2018 (16-17 May, Birmingham) is up 35% compared to the inaugural ...

FDA issues mandatory recall of Salmonella infected products

After several food products were found to contain salmonella, the US regulatory body has issued its first mandatory ...

Compliance and quality assurance turn digital

Companies are reaping the benefits of the shift from paper-based records and storage to a digital platform. Mark ...

FDA issues concerns for Aurobindo manufacturing plant

As Indian Aurobindo expands its sterile and biologics manufacturing overseas, its plants in India continue to run into ...

MHRA publishes GXP data integrity guide

Latest document comprises Good Clinical Practice, Good Distribution Practice, Good Laboratory Practice, Good ...

Action plan for ATMP

The new GMP guidance for advanced therapy medicinal products (ATMP) will become effective in May 2018. Axel Schroeder, ...

FDA proposes to recall Cantrell Drug products

The US Food and Drug Association has reported deficiencies in quality and sterility of compounded drug products at the ...

SEFA joins forces with SGS

Partnership agreement opens a new chapter for the laboratory furniture testing sector

Starting a sterile compounding pharmacy

Modular cleanroom expert Mecart provides a step-by-step guide to sterile compounding pharmacy as recommended by ...

Checklist to comply with EU Biocides Regulation 528/2012

Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance ...

Highly potent APIs: hazards in classification and handling

This variability and subjective nature of classification means that the OEL is best considered as a tool for site risk ...

FDA updates duodenoscope surveillance protocols

The US Food and Drug Administration will host a webinar in March focusing on new voluntary duodenoscope reprocessing ...

Micronclean gains BSI approval for new cleanroom

The sterile syringe packs produced by the UK manufacturer can now be sold to customers worldwide