Cleanrooms are used in a wide variety of industries, from manufacturing and pharmaceuticals to biotech and aerospace, to reduce contamination and to control other environmental parameters such as temperature, humidity and pressure.
Similar to cold rooms, they vary in size and complexity – but if designed and built by MTCSS, we can ensure they suit the exact requirements of your industry and specification.
Cleanroom Design, Delivery and Installation Times
As a type of temperature-controlled room that has specific classifications and requirements, the delivery and installation of your cleanroom needs to be precise and careful.
MTCSS handle each cleanroom installation, from initial site survey through to commissioning and validation, handling the entire process in-house so you have a single point of contact from enquiry to handover and working around your operational requirements to minimise disruption.
Once a design is agreed – covering ISO classification, HVAC and filtration, pressure differentials, and airlock or gowning requirements – our team manages the full build, complying with:
- BS EN ISO 14644-1
- Any applicable regulatory standards, including GMP, FDA, and USP
Before commissioning or validating your cleanroom to its certified classification, and handing it over to you.
We can also ensure smooth after-sales support, as well as routine maintenance, too – so you know the investment in your business will be kept in the best condition for as long as possible.
To discuss your project, call us on 01886 833 381 or email sales@mtcss.co.uk, and we’ll get back to you.
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Industries we can Assist with Cleanroom Installation
- Pharmaceutical manufacturing
- Biotechnology and life sciences
- Medical device manufacturing
- Aerospace and defence
- Electronics manufacturing
- Food and drink manufacture, including specialist fields, such as infant formula
- Cosmetics and personal care goods
- Automotive component manufacture
- Military and national defence
- Research laboratories
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We’ll learn your business inside out to design the ideal cleanroom solution for you.
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Bespoke Cleanroom Designs as Standard
Handled in-house with an experienced team, MTCSS can bring your cleanroom or compounding chamber needs to fruition, from design to thoughtful aftercare. This includes considering cleanroom classifications and temperature control.
Different Cleanroom Classifications
The regulations and standards that a cleanroom needs to meet will be dependent on the application and the industry in which it is being used. No matter which you need to work between, our experienced team will ensure your design complies with the specific regulations to achieve the certifications and validations required.
This includes ISO 5 to 8 class standard, the FDA, and ISO-14644 regulations. For example, in pharmaceuticals, you will certainly have to comply with GMP.
Temperature Control in Clean Rooms
HVAC design in cleanrooms is not only driven by the cleanliness of the room, but also by the temperature required, the humidity, and the pressure differential. These requirements are defined by the processes involved in the cleanroom and the comfort of the personnel working within the cleanroom.
The temperature and relative humidity of the room are major factors in the design of HVAC for cleanrooms. So, during the in-house design process, the heat produced by personnel and the equipment will be considered to be compensated by the temperature control.
What we Need to Know to Design a Cleanroom
Designing a cleanroom has more moving parts than designing a ‘typical’ cold room, so the information that we need to create a cleanroom to your requirements is more detailed.
The level of cleanliness in your cleanroom will determine the ISO class required for your rooms. These classes are sometimes enforced by a guideline (such as USP, GMP, or FDA), or they can be defined by your company’s internal quality policy. Cleanrooms at ISO 8 and above also require an airlock.
- What size cleanroom is required?
- What are your door and window requirements?
- If you require any antechambers/gowning rooms/airlocks?
- Do you need any washing stations?
- What level of cleanliness do you need?
- What are the processes that will take place inside the cleanroom?
- What ISO class must your cleanroom adhere to?
- Are there any other specific regulations & standards that need to be adhered to?
- Are you using any specific chemicals/solutions/solvents?
- The required temperature – including the setpoint and tolerance
- The humidity and pressure differential
- The ambient temperature in the space where the cleanroom will be built.
- How many people will be working in the cleanroom
- The equipment in use
- The heat any equipment generates
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Compounding Chambers
Compounding chambers are a form of cleanroom utilised for sterile compounding pharmacies – compounding chambers are where the process of mixing drugs takes place in a strictly controlled (temperature & humidity) cleanroom.
Three main factors that determine the regulations that apply to a compounding facility: the type of preparations being compounded, the geographic market the facility operates within and the geographic market the compounded preparations will be sold.
The HVAC systems utilised within compounding chambers are vital, from the pressure and humidity control to the temperature control and air conditioning systems. Air conditioning and humidity are key elements to ensure the comfort and safety of personnel working within the compounding chamber.
What we Need to Know for Compounding Chamber Design
- The type of products being compounded – non-hazardous sterile compounding preparations; hazardous sterile compounding preparations; hazardous non-sterile compounding preparations; non-hazardous non-sterile compounding preparations
- The regulations required – USP-797; USP-800; ISO 14644-1:2015; NAPRA
- These regulations are dependent on the pharmacy regulatory authority of the location the facility is located and where the compounded preparations are sold
- Other considerations to take place are similar to that of cleanrooms (as listed above)
Are Cleanrooms Energy Efficient?
As they can consume 30-50 times more energy than typical commercial buildings because of intense airflow, filtration, and environmental control requirements, cleanrooms aren’t generally energy efficient – unless you design them to be.
To make them more energy efficient, MTCSS can design compliant spaces that:
- Lower air changes during unoccupied periods
- Use high-efficiency motors
- Optimise filtration
- Reduce set points for temperature and humidity tolerance
All of which can reduce energy usage by as much as 50%!
Cleanroom Installation Without the Compromise at MTCSS
Whether you are looking for maintenance, refurbishment, or a new installation, we can help.
MTCSS Contracts will discuss your requirements regarding layout (including buffer zones, PEC, anterooms, and AHU), HVAC systems, and ensure your design adheres to any specific regulations key to your industry.
To get a quote today, call us on 01886 833 381, or email us at sales@mtcss.co.uk, and we’ll be in touch.
Cleanroom Frequently Asked Questions
In the UK, the classification is by BS EN ISO 14644-1, which is the compliance with ISO 1 to 8. However, there are other cleanroom classifications to consider, depending on your country, industry, and application. Pharmaceutical cleanrooms may need to comply with other specific regulations, certifications, and validations.
Cleanrooms are utilised in a wide range of industries that require adherence to a specific range of classification in relation to air cleanliness, including pharmaceuticals, biotech, and aerospace.
Compounding chambers are a type of cleanroom that is used in sterile compounding pharmacies – essentially where the process of mixing drugs takes place.
The best way to keep your cleanroom hygienic is to:
- Implement regular cleaning routines (daily and weekly)
- Stringent disinfecting
- Sterile packing techniques
- Strict monitoring and controls
- Workflow optimisation
- Regular maintenance and repairs as needed
If you need assistance, please contact our team to enquire today!
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