Joan Benson, regulatory governance & assurance manager at Connect 2 Cleanrooms, explains how to begin manufacturing in-house in a climate short on contract manufacturers.
Dan Tidswell
Connect 2 Cleanrooms (C2C) 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.
The drought in contract manufacturing capacity is partly fuelled by the recent trend for pharmaceutical and medtech industries reshoring manufacturing activity due to the global disruption because 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. However, what’s ultimately more daunting, is the risk of not taking this step. There is a significant risk that the development of important routes to market, such as clinical trials, will be halted.
Just as the medical device industry is governed by its own set of standards, cleanrooms must conform to ISO 14644-1:2015. The standard contains a range of classes with clearly defined particle concentration limits that determine the cleanliness of an environment. A cleanroom must be designed to achieve the appropriate class of air cleanliness and the nature of the process often dictates the classification required.
EU GMP-compliant cleanrooms will also be classified according to the test methods in ISO 14644 but may have different limits and may require additional testing.
Let’s look at some of the applications for ISO 14644-1 and EU GMP cleanrooms in the medical device fields and the crossover between the two standards.
Medical devices are regulated by the Medical Devices Regulations (MDR) 2002. All medical devices are given a classification depending on the level of risk associated with the device. The strictest control is for products with the highest risk.
- Class I - generally regarded as low risk
- Class IIa - generally regarded as medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk.
Most cleanrooms intended for the manufacture of medical devices must comply with ISO Class 5 to Class 8 standards, however all active implantable medical devices and their accessories fall under the highest risk category (Class III).
A Class III Medical Device includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device. These devices should be manufactured in a GMP cleanroom. Aside from the initial investment required, in-house manufacturing can bring big benefits to organisations—such as greater control over production runs and quality standards.
ISO and MHRA-compliant manufacturing environments that are suitable for activities regulated under GMP can be installed into existing buildings, or even into modular cabins if space is at a premium.
There is no doubt that bringing manufacturing in-house would require transformational change within an organisation, but this risk can be mitigated within projects by using 3D digital modelling to offer a unique preview of the cleanroom facility before it is built. This enables organisations to optimise the layout, simulate work and materials flow, and check maintenance-related activities upfront.
Over the years, C2C has developed proven envelope solutions and reliable HVAC concepts for many applications. All cleanrooms meet their required ISO classification, and some systems can also be qualified to EU GMP. In-house regulatory expertise allows C2C 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.
