The company delivered a comprehensive package of support to make the regional QA Audit a success that resulted in operational approval being granted
The Royal Marsden NHS Foundation Trust hospital in Chelsea has received approval to open its new chemotherapy and gene therapy cleanroom suites, thanks to valuable assistance at all project stages from Validair Diamond Scientific (VDS).
The company delivered a comprehensive package of support to make the regional QA Audit a success that resulted in operational approval being granted.
Key members of the Royal Marsden clinical team acknowledged the role of Validair, singling out the support of Steve Ward, VDS Managing Director, for special praise. Ward points out that the validation project was a ‘cradle to grave’ initiative supported by a team from Validair, starting with assistance on the User Requirement Specifications preparation, and moving on to the delivery of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). But additional support was needed suddenly.
“I received an urgent phone call from the Royal Marsden during the day of the audit,” explains Ward. “I was asked to hurriedly join an online meeting as my expertise was required to clarify some technical aspects of the qualification process and cleanroom design philosophy to the auditors. The Royal Marsden team had been explaining the benefits of turbulent flow to reduce the chance of dead spaces in a cleanroom, the auditors were unclear and remained unconvinced. Fortunately, I was able to put that right.”
Senior managers at the Royal Marsden have since written to Validair expressing their gratitude for Steve Ward’s timely intervention. They explained that the Hospital’s in-house team learnt a lot from his expertise while the auditor’s confidence had been restored, resulting in the green light. The new cleanroom suites are now operational.