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CLEANROOM CONSTRUCTION


Cleanroom and laboratory design and construction specialist, Boulting Environmental Services (BES) has completed the construction phase of a £13 million project for global pharmaceutical business and world leader in the treatment of opioid addiction, Indivior. The new research and development (R&D) facility will test and manufacture a non-addictive alternative to methadone.


A


ddiction is a growing global crisis with 29 million people between the ages of 15 and 64 thought to have been suffering from drug use disorders or drug


dependence in 2016. In the UK alone, the number of people dependent on opioid painkillers is estimated to be as high as a million. Indivior, which has its global HQ in Richmond Virginia and a UK base in Slough. opened its new state-of-the-art research and development centre in Hull in August, following a $30 million investment. The company’s vision is that all those suffering from addictions will have access to quality treatment for their conditions and co-occurring disorders including alcohol abuse and schizophrenia. Shaun Thaxter, Chief Executive Officer


of Indivior, said, “Indivior’s focus on the needs of patients can be traced back decades, to the days before buprenorphine was discovered – right here in Hull – and developed as a treatment for opioid addiction.” Rochdale company Boulting was the principal designer and contractor for the project, carrying out a complete turnkey package that included groundwork, piling, shell construction and the internal specialist architectural fit out of cleanrooms and laboratories. The two-storey so-called Current Good


Manufacturing Practice (CGMP) facility provides 5,000 square metres of ISO7 and


12 /// Cleanrooms & Contamination Control 2017


Cleanroom constructor completes pharmaceutical facility build


WHAT IS CGMP?


CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. The FDA regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulation for human pharmaceuticals. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. Adherence to the CGMP regulations


assures the identity, strength, quality and purity of drug products by requiring that manufacturers of medications


ISO8 product development cleanrooms and laboratories, along with highly specified offices, meeting rooms and a restaurant for staff. “Indivior selected Boulting


Environmental Services through a competitive tender process, in which BES came out on top in terms of cost-effectiveness and delivery time,” commented Paul O’Reilly, facilities director at Indivior. “The design and build process was extremely collaborative, with BES listening to our primary objectives and creating a facility that was both technically fit-for-purpose and one that gave Indivior welcoming office space and recreational areas for staff.” Due to the nature of the facility, a full


inspection from the Home Office was required after construction. The auditor not only gave the building approval, but referred to it as state-of-the-art – a testament to the quality of work that Boulting Environmental Services carried out on the site.


adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations and maintaining reliable testing laboratories. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures and errors. This assures that drug products meet their quality standards. It is important to note that CGMPs


are minimum requirements. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.


“Boulting Environmental Services


completed the project three months ahead of schedule, within budget and to the highest quality,” explained Giles Singleton, project manager at Boulting Environmental Services. “This was down to our lean programming framework and our ability to overlap different phases of the project to eliminate wasted time. In this way, at no point were our engineers waiting for one task to be completed before they could move on to the next. The entire process was efficient and streamlined with the customer’s requirements in mind at all times.” The new R&D building will be named


the Chapleo Building after Dr Chris Chapleo, one of the founding fathers of Indivior and spearheaded the scientific quest to develop buprenorphine-based treatment. Chapleo is currently a Fellow of the Royal Society of Chemistry and former Chairman of the Society for Drug Research. EE


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