Regulations are in some cases open to interpretation and it is up to the individuals to justify any interpretations made with real world data and suitable scientific analysis. Sometimes though, buildings constructed over a decade ago require a re-assessment against current expectations, with a realisation that what was fit for purpose at the time of construction may no longer be so. It became apparent that our current sterility room, housing our 2 Isolators, did not meet the current interpretation of the regulations.
From that moment, we knew that the room built in 2007 was going to have to retire from duties.
Planning for the future. Four heads, one boardroom and an orange guide.
This was the start of the journey to equip Tepnel with a state-of-the-Art Grade D Clean Room. Four heads are better than one: drawing on different sets of expertise, each bringing a different perspective and value, the team worked together efficiently and progressively to ensure that we achieved our end goal.
The Quality Manager ensuring the regulatory boxes were all ticked; a microbiology Project Manager devising exactly what was needed to make it work for the end user; the Facility Manager finding the right space within the facility, ensuring it would work to maximum mechanical efficiency; the Senior Director exploring the commercial needs to ensure that the resources invested will be meeting customer needs for years to come.
Selecting the correct supplier to take with us on the journey
It was critical that the right partners were found to join the team. This was never going to be a transactional process but by adopting a Vested approach and armed with the URS that met all the regulatory requirements, a partner was chosen that understood the desired outcome and were prepared to work with us to deliver it. All the vendors approached offered large portfolios of how to build bespoke clean rooms and all pitched in very different ways of how they could deliver a Cleanroom fit for purpose. After much discussion, the project was awarded to Bassaire. The contracts were then signed and the drills and tool boxes were locked and loaded!
Breaking down walls but not customer relations
Throughout this project, a key factor was to ensure that there was no adverse impact on the quality of our service delivery to customers.
The ambition was to ensure zero down time and this guiding principle was behind every decision and every avenue we went down. Although it was tricky at times, solutions were found by being flexible and by deciding to utilise an alternative space rather than retro-fitting the existing Sterility test room. Precise planning allowed us to continue offering sterility testing to our customers throughout the build. From the first cable being stripped out to the isolators being housed, the first set of testing in the new fully validated room was achieved in 15 working days. They were 15 long working days for the Facility Manager and construction engineers, but the time and effort was put in to ensure our customer and patient needs were not impacted.
Happy customers, both internal and external
The confidence of the Facility Manager in the team meant that he never worried about meeting the handover of the room to the Microbiology department. This was because throughout the process they were proactively involved as end users. From the colour of the floor and wall surfaces, to the location of the power outlets and activity space design, their input was key to ensuring a smooth handover and a functional room, resulting in happy customers with no impact on deadlines.
Without the input of the above mentioned, the result would not have been possible.
As we say in Tepnel, “TOGETHER WE ARE BETTER“.
Richard Hastings, Facility Manager
Tepnel Pharma Services is a GMP quality control analytical laboratory based in Scotland. From a custom designed facility in Livingston, we provide analytical services that support the drug development process and the batch release testing of market authorised products.