Andreas Montag, business development director Medical at Sumitomo (SHI) Demag and regional sales director Andrew Sargisson discuss what’s driving the growth in the cleanroom markets.
Sumitomo (SHI) Demag
The global cleanroom market is on another growth curve. BCC Research indicates that the global market for products manufactured in a cleanroom environment is expected to grow in value from $7.5 billion in 2023 to $10.9 billion by the end of 2028. While maintaining a sterile environment is clearly essential to meet the defined regulatory standards and to ensure the safety and efficacy of medical device products, a cleanroom is so much more than just a white space occupied by people wearing gowns, masks and other PPE.
Standards and guidelines
Most medical moulders will only embark on cleanroom projects to fulfil regulatory FDA, GMP Annex 1 and CFR Part 211 requirements. These regulatory bodies all publish guidelines and have regulations for cleanroom designs.
In order to comply with these requirements, the equipment used in the manufacture, processing, packing or holding of a drug product needs to be of an appropriate design, adequate size and suitably located.
Cleanroom classifications
A cleanroom is assigned a rating between ISO Class 1 through to ISO Class 9, dependent on the number of particles per cubic metre of air. The lower the cleanroom class, the cleaner the environment. ISO 7 and ISO 8 cleanrooms are typically adequate for most medical device manufacturing processes. ISO Class 5 cleanrooms for sterile medical components are only required if products are exposed to the air or surfaces. A fully configured all-electric injection moulding machine can be a straightforward way to create an instant cleanroom and eliminate one of the biggest contamination risks … people.
Three essential characteristics
To achieve a controlled cleanroom environment, all three categories must be addressed:
- Internal surfaces and the equipment contained within the cleanroom should be designed to mitigate contamination and be easy to clean.
- Filtered air flow is required to maintain a stable temperature and humidity while simultaneously extracting particulate contaminations.
- Operational standards, including maintenance, training staff and adhering to robust procedures, must always be maintained.
Keep it simple
It is common for people to submit a user requirement specification (URS) request for a cleanroom solution that is superfluous to the medical component being made. Most do this out of regulatory fear.
It is important to note that over-committing to a cleanroom classification could leave medical manufacturers exposed to unwarranted compliance requirements that, once approved, you must continue to adhere to. Sometimes effective ventilation is all that is required. Yet, for sterile medicinal products, the requirements - defined by Annex 1 of the EU and PIC/S GMPs – are stringent.
Be more energy aware
As filtered air-controlled production environments, moulding cleanrooms are extremely energy intensive. Experts estimate that in some cleanroom facilities, the air units that circulate fresh air and extract particulates can consume around 60% of all production power.
In order to conserve energy, look at your white space. If non-utilised areas can be occupied by additional machinery, this increases production capacity without powering a separate room. A lower ceiling height can also help to reduce the overall atmosphere that requires HEPA filter control.
Identify heat sources
Over cluttering is not conducive to the GMP standards. Remove free-standing periphery equipment from the floor and integrating into the moulding machine cell, including hot runner controllers, cables, and even automation, as this eliminates another surface area and consequently additional sources of heat generation.
Integrated electric direct drives is another consideration. Providing the force transmission, these use considerably less energy. As no belts are spinning, the drives don’t have to work as hard. In turn this means the machine isn’t overworking itself. Thermal imaging can provide a good indicator of any inefficiencies and heat emissions.
Clever design features
A large platen area can increase productivity as a machine can accommodate higher cavity tooling. Additionally, look for integrated laminar air flow systems which can flood the mould surface and part handling areas with HEPA filtered air.
As a benchmark, the IntElect Medical package comprises GMP-compliant technical features, such as raising the machine 100mm off the floor to help maintain cleaning standards. Additionally, total stainless steel fixed platen coverage on the top, sides and underside without any cut outs ensures air flow is not disturbed. Inside the cell, yet outside the mould space, cooling, temperature and pneumatics can be attached. Eliminating cables and hoses in the mould space.
OPC-UA interoperability
Designed to enhance traceability and optimise processing stability, medical manufacturers can now extract all performance data from the machine and all the contained periphery equipment.
Recording time series data and analysing process parameters, an OPC-UA interface records, channels and collates every processing aspect from all the peripheral devices attached to the cell. This contextualised data is then submitted from the beating heart of the production cell, straight to production and QC managers. Without people needing to enter the cleanroom environment.
Seek global expertise
Never underestimate the value of high-quality consultancy at the start of any medical cleanroom project. Having access to global technical experts that are all GMP-trained and regularly provide cross-border support makes it much easier to manage each of the defined steps for design, installation, operational and production Qualifications and Validations of cleanroom machinery.