Connect 2 Cleanrooms is hearing from more and more organisations that have traditionally outsourced manufacturing but are now finding contract manufacturers have no capacity. Faced with the threat of not being able to outsource this vital service, organisations are investing in cleanroom facilities to bring manufacturing in-house and in this blog post, our Regulatory Governance & Assurance Manager, Joan Benson, explains how to get started.
The drought in contract manufacturing capacity is partly fuelled by the recent trend for pharmaceutical and med-tech industries reshoring manufacturing activity due to the global disruption as a result of the Covid-19 pandemic. Another contributing factor is that many facilities that have previously been available for contract manufacture have been required to repurpose into other areas, such as vaccine production.
Companies who have no previous understanding of specifying or project managing a new cleanroom build may find this daunting. We are here to help those companies, as we realise that without taking this step, there is a significant risk that the development of important routes to market, such as clinical trials, will be halted.
Aside from the initial investment required, in-house manufacturing can bring big benefits to organisations—such as greater control over production runs and control over quality standards.
We can support by providing MHRA-compliant manufacturing environments, for activities regulated under GMP. Applications may range from aseptic processing, medical device manufacturing, advanced therapy medicinal products (e.g. cell and gene therapy), and many more.
No doubt bringing manufacturing in-house would require transformational change, but we mitigate risk within projects by using 3D digital modelling to offer a unique preview of the entire facility before it is built. This enables us to work with clients to optimise the layout, simulate work and materials flow, and also check maintenance-related activities upfront.
Over the years, we have developed proven envelope solutions and reliable HVAC concepts for many applications. Our systems meet the required ISO classification and can also be qualified to international GMP. Our in-house regulatory expertise allows us to input on the client’s user requirement specifications (URS) to make sure the planned facility will be compliant and the necessary regulatory standards achievable.
As for authorisations; standard pharmaceutical manufacturing can be done under an MA (marketing authorisation), clinical trials under an MIA (IMP - investigational medicinal product licence), or Specials manufacturing under a specials licence.
From small and simple facilities to large-scale facilities with multiple zones, we can custom-build to suit your requirements.
From contract sterilisation to in-house sterile/aseptic filling
Capacity issues are not just limited to contract manufacturers, as organisations are also finding it hard to source contract gamma irradiation sterilisation. The need for this service may be removed altogether if organisations implement aseptic filling instead.
If you start with a sterile product or sterilise by filtration, you can use an EU GMP Grade A filling area, such as laminar flow cabinets, microbiological safety cabinets, or isolators in a Grade B background. Connect 2 Cleanrooms can provide you with a Grade B background for your Grade A filling area. Don’t forget, if you use isolator technology, this can be located in a lower grade background. Support areas, such as preparation areas and change rooms can be Grade C/D.
Recently, we provided the NHS Wales with a facility for its aseptic filling of intravenous drugs.
For more information or if you’d like to start a conversation with C2C about your project, contact us today.
Thanks for reading,