Some things to think about before designing a cleanroom.
-
Which class, regulations or other standards must you comply with?
Which class, regulations or other standards must you comply with?
The regulations and standards that need to be met vary with the applications and industry your company is involved in. A cleanroom used for sterile compounding of hazardous drugs is completely different from a cleanroom for pharmaceuticals or microelectronics. Depending on your industry and application, you might have to comply with an ISO 5 to 8 class standard, the FDA and ISO-14644 regulations. In pharmaceutics, you will certainly have to comply with GMP. For sterile compounding, NAPRA and USP 797/USP 800 will apply. We must make sure your design complies with the given regulations to get your certification and validation.
-
What are the required operating conditions in your cleanroom?
What are the required operating conditions in your cleanroom?
The HVAC design is driven by the cleanliness of the room (ISO class) but also by the required temperature, humidity, and pressure differential. These prescribed conditions are dictated by the process involved in the cleanroom and the comfort of the personnel working inside the room. The temperature and relative humidity (RH) precision (+/-) is also a major factor in the design of the HVAC. The heat produced by both the users and the equipment must be compensated by the air conditioning. Therefore, it is important to know how many people will be working in the cleanroom, the equipment in place and the heat it generates (watt).
-
Have you thought about how you would like your cleanroom to look?
Have you thought about how you would like your cleanroom to look?
Try to quickly sketch the layout of the cleanroom you need. The expression, ‘A picture is worth 1000 words’ takes on its full meaning in cleanroom design. It is also important to illustrate the movements/flow inside the room as well the entrance and exit of both material and personnel. Other design elements must be planned such as: how many doors and windows to integrate, where will the work benches be located, do you need airlocks, etc. If you are not familiar with cleanroom designs, start with a rough sketch of your operational needs and we will help you with the next step.
-
What do you do in the cleanroom and what part of the process will be completed outside?
What do you do in the cleanroom and what part of the process will be completed outside?
It is also important to define the processes that will take place inside the cleanroom, and what can be done outside. The more work is done inside, the bigger your cleanroom will have to be, the more heat and particles it will generate, the stronger the HVAC will have to be, hence the more expensive your cleanroom project will be. If any of the steps of the process do not have to be completed in a cleanroom, perhaps you should consider doing them outside the clean environment.
-
Will you be using a fume hood or a biosafety cabinet (bsc) in the cleanroom?
Will you be using a fume hood or a biosafety cabinet (bsc) in the cleanroom?
Some BSCs exhaust their air through a HEPA filter directly in the cleanroom without interfering with the cleanroom pressure while other fume hoods and BSCs must exhaust the air to the outside (hazardous drugs or other chemicals), which unbalances room pressure. To maintain the correct pressure in the cleanroom, we must compensate the air output with fresh air. To do so we must know the quantity of air exhausted by the fume hood or biosafety cabinet.
-
What space will you be working with?
What space will you be working with?
Once we know what the cleanroom will look like, we need to determine what its location entails.
- Where will you equipment such as HVAC be located?
- Do we need a mezzanine platform above the new cleanroom?
- What is the existing floor made of, is it concrete or timber?
- How accessible for plant and equipment is the available space for your new cleanroom?
- What power is available and is it enough?
- Where are the building services located within your building, such as water, storm water and sewer?
- Will the existing building be suitable for the expansion?
A list of Questions and Answers that are relevant to the Construction phase:
-
What is a laboratory?
What is a laboratory?
A laboratory is a facility that provides controlled conditions in which scientific or technological research, experiments, and measurement may be performed. Laboratory services are provided in a variety of settings: physicians’ offices, clinics, hospitals, universities, pharmacies, and manufacturing businesses.
-
What is the difference between a lab and a cleanroom?
What is the difference between a lab and a cleanroom?
A laboratory is a space dedicated to scientific research, experiments, and testing, as well as the manufacture of certain types of products. There is nothing in this definition that requires the laboratory environment to be controlled in any way. While a pharmaceutical manufacturer might have a highly controlled laboratory environment, a local high school might also have a lab, wherein students conduct experiments under no environmental controls.
When you are in the business of manufacturing, whether pharmaceuticals, food, beverage, or industrial products, quality is always a critical concern. When quality control is paramount, you must test products, and most of that testing likely occurs in a lab. Some products will even need to be manufactured in a laboratory setting. But usually, your laboratory is not the right environment to ensure quality in your manufacturing processes. If it is just a lab in name only, then it is not a true cleanroom.
-
What is a cleanroom?
What is a cleanroom?
A cleanroom is a controlled environment, specifically one that controls the level of contamination from particles, along with other factors such as temperature, humidity, static electricity, etc. Controlling all these variables protects your processes and products from contamination or conditions that could compromise the integrity of those products and processes.
Cleanrooms are required to meet specific standards as to the number of particles acceptable within the space, and to meet that standard, the cleanroom is regularly tested. Equipment and systems are put in place to maintain the cleanroom environment, including filtration systems, air flow systems, and access control procedures for entering the spaces, such as airlocks (MAL and PAL), Pass through boxes, Air showers for both materials and people. Lab coats or gowning for personnel working in the cleanrooms. In a nutshell, clean rooms are those rooms that meet the code of GMP requirements as defined in the sterile code of GMP, i.e. Annex 1 of both the EU and PIC/S Guides to GMP and other standards and guidelines set by local health authorities.
-
Why do you need a cleanroom instead of just a lab?
Why do you need a cleanroom instead of just a lab?
If you are not controlling your laboratory environment, there is really no point in having one. It is not going to ensure product quality, and safety and these things are critical for sound manufacturing processes. As an example, industries like electronic manufacturing, pharmaceutical, Aerospace, and Defence, cleanrooms are either required by law or are enforced as an industry standard.
-
What is the difference between a cleanroom & a containment facility?
What is the difference between a cleanroom & a containment facility?
A containment facility is a specialised space which ensures that materials within the area do not migrate from the facility to the general environment. The containment facility may be a cleanroom, but additionally have additional controls and standards to handle the materials effectively within.
Containment facilities are used to handle live viruses and bacteria such as COVID-19 (SARS-CoV-2) and many other sensitive materials such as genetically modified organisms and materials governed by the Office of the Gene Technology Regulator (OGTR), cytotoxic materials, steroids, hormones, and beta-lactams (i.e., penicillin).
The classification of containment facilities is different depending on the usage of the area. There are many different containment methodologies, these are:
1) Physical containment (PC 1-4), requires certification in Australia by the OGTR,
2) Biological Containment (Biological Safety Levels, the four biosafety levels are BSL-1, BSL-2, BSL-3, and BSL-4, with BSL-4 being the highest (maximum) level of containment. BSL-4 facilities are typically designed to handle materials such as the viral haemorrhagic fevers (VHFs) group of diseases comprises Lassa fever (LF), Congo-Crimean haemorrhagic fever, Ebola and Marburg virus infections. There are additional specific rules and designations for animal research (ABSL), agricultural research (BSL-Ag), and other types of research,
3) Industrial Hygiene and Toxicology – requires the suitable design of the facility to safely handle and control materials which have a low therapeutic dose (High potency) (i.e., cytotoxic compounds, beta-lactams, poisons, steroids, and hormones). The evaluation and design are based on toxicological data for the materials used or made in the process and containment levels are based on the potential therapeutic dose. Facility design and engineering controls are used to limit exposure to staff and environment. PPE is a last resort in contamination control. These facilities are commonly referred to as high potency facilities. The acceptable levels are specified and governed by SafeWork Australia. References for the contamination control for industrial hygiene applications are.
a. Toxicologist,
b. Safe Work Australia,
c. Safe Bridge,
d. ISPE Risk MAPP,
e. National Institute for Occupational Safety and Health (NIOSH) – USA.
-
Who needs a cleanroom?
Who needs a cleanroom?
Cleanrooms are used where the processing and handling of materials under normal room conditions would result in contamination of the product and process. The complexity of the cleanroom is commensurate with the process requirements.
-
What type of cleanroom do I need?
What type of cleanroom do I need?
This is a difficult question to answer at times as it is specific to the application. TPC can assist in providing guidance for the requirements of the cleanroom for your application. We have many years of experience in the health and life sciences industry to guide you through the specification and design of your new cleanroom facility.
-
What makes a cleanroom a clean room?
What makes a cleanroom a clean room?
A cleanroom is typically kept clean by using filtered air supplies and large air change rates to replace the air within the cleanroom many times per hour. The filtration can be High Efficiency Particulate Air (HEPA) filters depending on the cleanroom requirements and classification. These filters are certified to ensure that there is no leakage of air which by-passes the filter, therefore all air entering the facility is filtered. In addition, the materials used to construct the cleanroom are also non-shedding and do not add to the particulate load within the facility.
-
Which industries need cleanrooms?
Which industries need cleanrooms?
Animal facilities (BS-rated and SPF)
API manufacturing
Blood plasma and serum processing
Biosecurity/biocontainment
Cytotoxic (HPAP)
Steroids / Hormones
Beta-lactams
Diagnostics
Food manufacturing.
Distribution/logistic centres/warehouses
Fermentation and cell culture (mammalian and microbial)
Laboratories (R&D, QA, QC)
Medical devices
Packaging
Pilot plants
Solid dose, liquids, and creams
Sterile processing
