Created by Decontamination and Decommissioning of UK Pharmaceutical R&D Sites: a Radiological Protection Perspective Vincent Hart, Alan S Muir* and Glenn Hardcastle^ *EHS Services, GlaxoSmithKline R&D Ltd, Stevenage, UK ^Aurora Health Physics Services Ltd, Harwell, UK Introduction The UK pharmaceutical R&D sector has for many years been a major small user of radioactive materials: usage of the traditional life-sciences radionuclides [C-14, H-3, I-125, P-32, P-33, S-35] predominates although recent scope has extended to include PET imaging materials. The current economic climate and other drivers have led to recent major reassessments of established medicine/drug discovery paradigms resulting in further sector rationalisation, leading to the closure and divestment of some well-established R&D sites. Radiological decontamination and decommissioning of such premises before disposal is essential. Such operations present a variety of challenges including stringent regulatory requirements, timescales, costs, site history, accessibility of records, loss of local expertise and other non-radiological hazards. This poster outlines the generalities of the radiological decontamination and decommissioning strategy adopted by a major UK pharmaceutical company prior to the recent divestment of two major R&D facilities. Key Challenges Timescales and costs Regulatory requirements Availability of key staff Credibility of anecdotal information Incomplete records/history including pre-occupancy Reputational issues Stakeholder expectations/due diligence requirements Project Areas General access areas All areas where radioactivity was used or stored Drains [internal and external] and extract ductwork Containment devices Special areas [incinerators, sumps etc] Outside grounds/heritage areas Sealed sources Smoke detectors/tritium light devices A radiological decontamination/decommissioning strategy for the site needs to be established early on in the project and outcomes agreed with the regulators and other stakeholders. The strategy should be predicated on an assessment of radiological risk derived from available information sources such as records of radiological use and disposal, locations, site and building plans, service plans, records of regulatory correspondence and recollections of existing/former employees. The strategy should cover the management of any contaminated wastes arising during the process and where possible should define remediation end- point /clearance level criteria. In-house radiation protection expertise was used to assess and sift the initial information gathered, and then independent external radiological consultants were engaged to review this information and conduct/project manage agreed further decontamination and the decommissioning aspects of the work. Regulatory Issues The ultimate objective of the radiological decontamination and decommissioning strategy is to achieve surrender of relevant regulatory permits as issued under EPR(RSR)2010 [Environmental Permitting Regulations (Radioactive Substances Regulations)2010]. Reports and documentation related to this form an important part of the portfolio of evidence submitted to the regulator [Environment Agency] as part of this process: thus regulatory agreement for the strategy should be sought early on. Additionally such reports will form a significant part of any due diligence requirements associated with site divestment. Such work must also be carried out in a safe and responsible manner by experienced and suitably trained staff. Prevention/minimisation of potential personal exposure to radioactive materials or radioactively contaminated materials is an essential requirement under IRR99 [Ionising Radiations Regulations 1999]: however other potential hazards [biological, chemical, physical, asbestos etc] may often present a greater risk to staff /others and must be also considered as a part of the risk assessment process underpinning the entire decontamination and decommissioning strategy. Conclusions This poster has outlined the general strategy adopted by GSK and its expert external radiological experts [Aurora Health Physics Services] in the radiological decontamination and decommissioning of two major pharmaceutical R&D sites in the UK. Significant effort was required in the gathering and interpretation of relevant historical, heritage and current information about radionuclide usage on the sites to facilitate the development of a risk based decontamination and decommissioning strategy which was agreed with the regulator at the earliest opportunity. Preparation of suitably detailed reports for the various stages of the strategy provided a sound basis for both the EPR(RSR)10 permit surrender process and the provision of accurate information to potential site purchasers as part of an established due diligence process. The levels of radioactive contamination detected on the sites during the process have in general been very low, indicative of the good radiological practices in place during the working life of the sites. Strategy Some Practical Aspects Initial risk assessments Confirmation of radiological status by survey/sampling Waste segregation Waste containment/reduction [Best Practicable Means approach] Prevention of contamination spread Difficulty of access to some engineering areas Difficulty deconstructing fume cupboards Pressure jetting/endoscopy for external drains Clearance levels and use of mass/activity averaging Support from key onsite staff Research/ information gathering In-house review of risks Initial strategy development Initiation of decontamination/ decommissioning programme Final strategy development Engagement with independent experts Disposal of wastes arisings Final hand back of facilities/report Regulatory/ stakeholder engagement Select independent expert Radiological Decontamination/Decommissioning Strategy Process Areas of high activity usage Areas of low activity usage Areas of no known activity usage Special areas (incinerators, sumps, etc) Drains (internal and external) and ductwork Strategy development Non-radiological hazards, such as: Biohazard Physical Chemical Confined Space Mechanical Environmental Heritage Strategy development pointers based on radiological risks Fume cupboards awaiting removal Weighing enclosure decontamination Sink trap removal Drain jetting