The Cart Block, Chestnut Court, Jill Lane,
Sambourne, Redditch, Warwickshire, B96 6EW
2024 © Copyright Airology Systems Ltd. All Rights Reserved.Company registration no. SC166192 VAT no. 670371639
Airology are experts in Pharmaceutical Cleanrooms.
We provide bespoke pharmaceutical cleanrooms to companies across the UK, designed to make the best use of space and meet the requirements of their processes.
There are clear regulations around pharmaceutical and medical manufacturing to ensure the safety of all consumers. We support our clients in designing and building a cleanroom that meets the correct specifications so that they can proceed with confidence.
Why do Pharmaceutical Manufacturers Need a Cleanroom?
Pharmacologists know that medical testing and manufacturing need to take place in a controlled environment. This reduces the risks of contaminating the product with particulate matter or microorganisms, such as bacteria or viruses.
Pharmaceutical cleanrooms are used to change and filter the air regularly, ensuring the lowest possibility of particle presence.
Medication Preparation Cleanroom
A medication preparation cleanroom is an indispensable facility in the pharmaceutical and healthcare industries for several compelling reasons. First and foremost, it ensures the utmost safety and purity of medications, particularly for sterile drug preparations. Contaminants, even in minuscule quantities, can have severe consequences on patient health, making the controlled environment of a cleanroom essential.
Second, cleanrooms provide a strictly regulated atmosphere, controlling factors such as air quality, temperature, and humidity, to prevent microbial growth and cross-contamination during the medication preparation process.
Third, these cleanrooms play a pivotal role in meeting stringent regulatory requirements and quality standards enforced by health authorities, ensuring that medications meet the highest safety and efficacy standards before reaching patients. In essence, a medication preparation cleanroom is vital for safeguarding patient well-being, upholding industry compliance, and maintaining the integrity of pharmaceutical products.
Vitamins and Supplements Cleanrooms (Nutraceutical Cleanrooms.)
Related, but somewhat different to a pharmaceutical cleanroom, is a vitamins and supplements cleanroom. Airology is your trusted partner for the design, installation, and maintenance of state-of-the-art cleanrooms dedicated to the production of vitamins and supplements, also known as nutraceutical cleanrooms.
Our specialised cleanroom solutions ensure the highest levels of purity and quality, meeting the stringent industry standards required for the manufacturing of these essential health products.
We provide comprehensive services, from creating custom nutraceutical cleanroom designs tailored to your specific needs to expert installation and ongoing maintenance, guaranteeing the integrity and safety of your vitamin and supplement production processes.
With Airology, you can have confidence in the cleanliness, precision, and compliance of your cleanroom, ultimately delivering the best quality vitamins and supplements to your customers.
Classification of Cleanrooms in the Pharmaceutical Industry
The classification of cleanrooms determines the number of airborne particles permitted per cubic metre of space. There are three main classifications that we work with: ISO, GMP and FED.
All of these classify cleanrooms based on the maximum allowable concentrations (particles/cubic metre) for particles of certain sizes for each class.
ISO standards, derived from ISO 14644-1, are numbered 1 to 9, with 1 being the cleanest and 9 being similar to any other, non-ventilated room.
For sterile drugs and biological products, businesses usually use the GMP (Good Manufacturing Practice) grades and classifications. These are graded A, B, C and D, with A as the cleanest and D being the least clean. Grade A and B cleanrooms are equivalent to at least an ISO 5 cleanroom when in use. Grade C and D are for less critical operations.
The requirements of your specific cleanroom project will depend on the intended use and design. Our cleanrooms are validated by an independent inspector on completion, so you can be confident that the installation meets ISO requirements.
What are the Requirements for a Pharmaceutical Cleanroom and Laboratories?
There are many types of cleanroom in pharmaceutical industry operations. Clean room standards for pharmaceutical production can vary depending on use. High-risk operations will require a higher grade of cleanroom specification, at least ISO 5 or GMP Grade A. Less critical steps can take place in ISO 8 or higher, according to GMP Grade C and D specifications.
Pharmaceutical cleanrooms may also require control of the temperature, air pressure and humidity, as well as the lighting conditions, depending on the compounds and products in use. The requirements of your specific cleanroom project will depend on the intended use and design.
Why work with Airology Systems for your cleanroom?
With over 25 years of experience in the cleanroom industry, we have extensive knowledge of cleanroom technology and classifications. With this knowledge and experience, we support you with the design and management of your whole cleanroom project, from initial concept to completion.
Once the design is finalised, we provide and liaise with specialists to install high-tech, high-quality solutions, creating a secure, controlled environment in your space. We are available for guidance throughout the project, by phone or email, and happy to offer advice where needed. On completion of the build, we arrange an independent validation assessment, giving you confidence that our solutions meet the specifications required.
Pharmaceutical Case Studies
Other Case Studies…
All
Pharmaceutical
Medical
Research
Technology
Medical Devices
Automotive
Defence