Connect 2 Cleanrooms offers a checklist of priorities for the successful installation and operation of a cleanroom
A quick Google search of the Top 10 inventions of the 21st Century comes up with the following list:
One of the common factors that makes all these inventions achievable is a clean environment provided by modular cleanrooms. A modular cleanroom construction is typically a freestanding, solid and robust structure that is suitable for use within an existing cleanroom, laboratory, manufacturing area or warehouse. A modular cleanroom uses off-the-shelf proprietary components to build a facility that meets the customer's exact requirements such as classification (ISO 14644-1), size, soft or hard wall (clear or opaque) and various lighting. As with all modular cleanroom providers there is a degree of consultation with the client to establish their desired criteria, the initial preparation paves the way to a smooth installation and a happy customer.
Potentially harmful particles exist in everyday critical manufacturing environments and can cause potential failure to production that is susceptible to contamination or everyday micro-organisms. The question is really: can you afford NOT to have a cleanroom? As processes and technology become smaller, particle contamination becomes a real issue. Contamination can cause serious product failure that could result in costly product recalls or in worst case scenarios can potentially be life threatening.
Once you have established the need for a cleanroom it is important to consider which type of cleanroom you require. Traditional cleanrooms are typically containment rooms, where the air is filtered and recirculated, integral to the building. Modular cleanrooms, on the other hand, work on positive airflow, drawing air through a HEPA or ULPA filtration system.
Due to the advancements of innovation and technology, modular cleanrooms have become an affordable and quick way to production for processes that require a clean environment. Dramatic design improvements include features such as hard PetG walls, sliding doors and transfer hatches, offering a customer much more choice and making the modular cleanroom a viable option for your mission critical environment. The Top 10 innovations listed previously required flexibility when developing their life-changing processes, and the option of mini environments and the modular cleanroom helped to expand their scope.
It is important to remain solutions-focused and understand the environment where a cleanroom will be situated as well as the process it will contain. Modular cleanrooms consider both: from the exceptionally small modular cleanroom, housed in a warehouse, part covering the packaging process of an injection moulding machine, to the large modular cleanroom housing a 100 strong workforce. The overall objective is to minimise risk to the process and consider the parameters of particulate count per volume of the room as well as pressure, temperature, humidity and lighting.
The Building Regulations Advisory Committee released the updated policy on 21 March 2014, providing effective building regulations so that new and altered buildings are safe, accessible and efficient. The policy ensures that building regulations are fair, efficient, up-to-date, safe and effective. A modular cleanroom does NOT require building regulations as it is a room within a room and not an integral part of a building. This incurs benefits such as, cost savings, less red tape and quick lead times. A modular cleanroom concerns itself with providing a solution for your process and not the alteration of your building.
ISO International Standards ensure that products and services are safe, reliable and of good quality. ISO 14644-1:1999 Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness is the standard to which all cleanrooms must conform.
The very nature of the process dictates the ISO classification required; for example, certain medical products implanted within a human body or certain food packing processes would need to be manufactured in a cleanroom with a higher classification than a non-critical process. For instance, a plastic lid manufacturer may only require a cleanroom for the production of lids that come in contact with food; this environment will need to be a higher ISO classification than less critical areas.
Always consider your process, determine the quality that you need to achieve using industry regulatory guidelines and if in doubt, speak to a reputable cleanroom company to gain professional advice.
Once you have controlled your airborne particles through your modular cleanroom environment, you should address the surface particulate and this is particularly important in the semiconductor, nanotechnology industries. Modular cleanrooms are used across many sectors including healthcare and medical device manufacturing, energy, pharmaceutical, electronics, laboratory and manufacturing – virtually any environment that is considered mission critical to your process.
A traditional cleanroom would involve numerous people within the business to plan the construction, from Building Manager, to Purchase Manager to landlords. A modular cleanroom is a much less complicated process; fewer people need to be involved in the planning, meaning a quicker lead-time to production. There is also the benefit of using standardised components which increases the project turnaround, such as fan filter units, gauges, powder coated steel. The very nature of a modular cleanroom means that you can start small and grow your cleanroom as production grows allowing you maximise on budgets.
A critical part of the modular cleanroom process is validation. Once a modular cleanroom has been installed, the cleanroom is validated to ensure that it is performing to the exact ISO 14644-1 specification as dictated by the customer. All manufacturing companies are used to ensuring that their equipment is calibrated and the validation service is the equivalent for a modular cleanroom. Good cleanroom practice would promote regular validations offering peace of mind plus it would tick the box for any external audits from clients.
Good practice dictates that a cleanroom should be kept clean before use and after use. People are massive generators of contamination and reputable cleanroom companies can offer gowning guides for assistance. There are now even free apps that can recommend clothing for the varying ISO 14644-1 classifications – Gown Me. Change areas are very popular in modular cleanrooms to help reduce the introduction of contamination. Raw materials and equipment used within the cleanroom also generate particle contamination. Double bagging of products, transfer hatches and a general awareness of your external environment will help to reduce contamination.
Reputable cleanroom companies will offer training/open days for their customers where demonstrations are held to promote best practice within a cleanroom. A modular cleanroom will add value to your processes by ensuring standards are met, particle contamination is reduced and clients are kept happy.