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Bioquell launches next-generation hydrogen peroxide vapour microbial eradication technology

BQ-50 is compact and automatically assesses all the influencing variables including room size and humidity level

Europe | Cleaning

ECHA demands information on biocides created during application and use

Otherwise products generating unregistered and unassessed ‘in situ’ biocides will have to be withdrawn from sale

Europe | Regulatory

Injection moulder chooses activeFlow

German manufacturer of oral dosing pipettes and injectors, elm-plastic, recently solved a problem of cleanroom production of flawless 8ml injectors in a 32-cavity mould with help from Sumitomo (SHI) Demag

Manufacturing and Equipment

Bioquell business review could lead to the sale of all or part of the company

Simplified structure and increasing investor interest in biopharmaceutical sector plus concerns about antibiotic resistance provide growth opportunities

Europe | Infection Control | Finance

FDA rule to address data gaps for ingredients in healthcare antiseptics

Product use should continue in the healthcare setting while additional data are gathered

North America | Regulatory | Infection Control

Aerosol packaging for sterile and medical products

The preferred format for many sterile alcohol products is sprays. Magnus Hedman, Aurena Laboratories, outlines some additional benefits of using Bag-on-Valve aerosols

Manufacturing and Equipment

Wyss Institute introduces new biosafety assessment process

The pre-emptive biosafety model looks to cover potential biosafety risks from new biotechnologies

Regulatory | Infection Control | Biotechnology | Pharmaceuticals

EO sterilisation: planning for future regulatory change

Exposure to ethylene oxide (EO) gas is a popular method of sterilisation for medical devices. However, manufacturers need to be aware of and addresss new standards and regulatory changes to ensure future compliance. Susan Birks reports

Regulatory | Cleaning

SLAC completes cleanroom for assembly of Large Synoptic Survey Telescope (LSST)

Starting in 2022, the 3,200 megapixel camera will take images of the night sky in unparalleled detail

Design and Build | North America

Designing pre-filled syringes for sensitive biologicals

Modern pre-filled syringes offer greater safety and ease-of-use but their development has not been without challenges in terms of contamination. Susan Birks reports on the latest developments designed to enhance the quality of sensitive biological drugs

Biotechnology | Pharmaceuticals

Nova Laboratories manufactures first aseptically spray dried biologic

Raplixa has been approved by the US Food and Drug Administration

Europe | Manufacturing and Equipment

Managing microbial risk in cosmetics production

The management of microbial risk in non-sterile manufacturing environments can be complex and companies may find out that a risk was badly managed only when things go wrong. Experts at Pharmig’s February conference, in Nottingham, UK, looked at best practice in managing the risks

Cleaning | Manufacturing and Equipment