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The pharmaceutical industry is generally risk-averse, which means new regulations will challenge current protocols like never before. James Tucker, marketing director of clean room contamination control specialist Ecolab Contamination Control explains.
SECTOR: Innovations
The pharmaceutical industry is generally risk-averse, which means new regulations will challenge current protocols like never before. James Tucker, marketing director of clean room contamination control specialist Ecolab Contamination Control explains.
The pharmaceutical industry is generally risk-averse, which means new regulations will challenge current protocols like never before. James Tucker, marketing director of clean room contamination control specialist Ecolab Contamination Control explains.
New, wide-ranging regulation changes are coming into force this year and pharmaceutical companies must comply, or face the consequences. The Biocidal Products Regulation (BPR), which succeeded the Biocidal Products Directive (BPD), removing the ability for country interpretation, is one of the regulations under the spotlight.
The changes are aimed at ensuring a high level of protection of human health and the environment. They also address the simplification and harmonisation of the authorisation procedures necessary to allow a company to market a biocide product for use across the EU. To ensure compliance, the BPR’s authorised list of active substances acceptable for use in biocides requires products to be registered with the European Chemicals Agency (ECHA).
Central to these new regulations is that biocidal products should neither be made available, nor used, unless authorised. This also applies to the purchase of raw materials with the intention of using them to biocidal effect, in-house.
The regulations apply to every manufacturer, meaning only products containing an approved active substance can be marketed legally. Failing to comply could incur fines and possible criminal proceedings for manufacturers and users.
Market impact should also be considered if the product can no longer be supplied. Ecolab Contamination Control is supporting its core range of biocides through the BPR with its regulatory department and is acting as a leader within consortia supporting the submission of actives.
The business also has EPA establishment registration* under different authorities. The manufacturing facility is EPA-registered, ensuring quality and continuity of supply. Meanwhile, manufacturers and importers of chemicals into the EU should review compliance with the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The latter requires companies to assess the health and environmental risks associated with the use of chemicals, and take appropriate steps to manage these effectively.
Ecolab Contamination Control preregisters every chemical it synthesises or imports. Any active ingredient registered with the BPR is part of the authorised list of active substances, acceptable for use in biocides. The non-active ingredients used in biocides are registered under REACH.
A further regulation relates to the packaging and labelling of products, as part of the new European Legislation for Classification, Labelling and Packaging of chemical substances and mixtures (CLP) and is based on the UN’s Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Although substances have needed to be classified and labelled according to CLP in the EU since 2010, from 1 June 2015, formulations or mixtures will also need to be classified. Some classifications will change, but Ecolab Contamination Control will not be altering any formulations because of CLP.
With the regulations starting to change from 2015, the industry needs to be ready. If a customer purchases an unsupported, or non-compliant product, they may be forced to make changes, or potentially cease production of their own products.
Ecolab Contamination Control’s investment programme guarantees compliance with the latest regulations, ensuring customers’ complete peace of mind and keeping the organisation at the forefront of delivering contamination control without compromise, allowing clients to focus on their own production.
*The EPA Establishment Registration number is 001677-GBR-001.
It is worth taking a moment to review the road that led to the long‐awaited update of Annex 1 of EudraLex Volume 4 ‐ Good Manufacturing Practice (GMP) guidelines. In 1989 the first edition of the guide ‘EudraLex The Rules Governing Medicinal Products in the European Union’ which amongst its volumes included Volume 4 ‘EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use’ was published, and included an annex on the manufacture of sterile medicinal products. A second edition was published in 1992, and further updating and re‐structuring of the guide followed. Annex 1 was also revised during the 2000s, but no complete review of the annex has been carried out since the last revision issue in 2008 – over 10 years ago. A complete rewrite has therefore been long overdue.
Download White PaperAs it is an employer's duty to protect the health, safety and welfare of their employees, the use of disinfectants in cleanrooms can present a significant challenge. This is especially true of sporicidal disinfectants which have a reputation for being aggressive and unpleasant to use.
