PPE for cleanrooms
and controlled environments
PPE for clean rooms is essential to ensure contamination control in critical environments such as pharmaceutical laboratories, the biotechnology industry, electronics and sterile production areas.
We offer a complete range of protective equipment for clean rooms, developed to meet the demanding requirements of these environments.
We work with certified solutions that ensure operator protection and process integrity in controlled environments.
Our products are selected to minimize particle release and ensure compatibility with different classifications.
Solutions for clean rooms and controlled environments
We offer a complete range of personal protective equipment for clean rooms and controlled environments, suitable for different levels of demand and industrial applications.
Cleanroom clothing
Coveralls, gowns and technical sets made from low particle emission materials with antistatic properties. Available in disposable and reusable versions.
Gloves for controlled environments
Nitrile, latex and vinyl, neoprene, CSM and EPDM gloves with sterile and non-sterile options, suitable for safe handling in critical environments.
Masks and respiratory protection
Solutions developed to reduce the risk of contamination of the environment by the user, essential in sensitive processes.
Footwear protection
Shoe covers and boots that prevent the introduction of external contaminants into controlled areas.
Complementary accessories
Caps, cuffs and other elements that ensure complete protection in clean rooms.
Discover how these environments guarantee high standards of quality, safety and compliance in sectors where even the smallest particles make a difference.
How to Select PPE for Clean Rooms
The choice of PPE for clean rooms must take into account:
- Environmental classification (ISO)
- More critical environments require higher levels of protection.
- Type of process
- Sterile operations require specific, certified PPE.
- Disposable vs reusable: More economical in the long term, reusable can present a greater risk of contamination with use and after multiple sterilization cycles, making it critical in more demanding environments. Disposables present greater contamination control.
- Compliance and certification
- Products must comply with standards applicable to the sector.
Applications in critical sectors
This equipment is used in various sectors where contamination control is critical:
- Pharmaceutical industry
- Research and quality control laboratories
- Biotechnology
- Electronics industry
- Hospital environments and sterile areas
Applications in critical sectors
ISO 14644 cleanroom classes: particle limits
Cleanrooms are classified according to the international standard ISO 14644, which defines the number of particles allowed per cubic meter of air. This table shows the limits for different ISO classes, taking into account various particle sizes. The lower the class, the stricter the contamination control and the lower the concentration of particles allowed in the environment.
ISO Class | 0.1 µm | 0.2 µm | 0.3 µm | 0.5 µm | 1.0 µm | 5.0 µm |
ISO 1 | 10 | (d) | (d) | (d) | (d) | (e) |
ISO 2 | 100 | 24 | 10 | (d) | (d) | (e) |
ISO 3 | 1 000 | 237 | 102 | 35 | (d) | (e) |
ISO 4 | 10 000 | 2 370 | 1 020 | 352 | 83 | (e) |
ISO 5 | 100 000 | 23 700 | 10 200 | 3 520 | 832 | (d), (e), (f) |
ISO 6 | 1 000 000 | 237 000 | 102 000 | 35 200 | 8 320 | 293 |
ISO 7 | (c) | (c) | (c) | 352 000 | 83 200 | 2 930 |
ISO 8 | (c) | (c) | (c) | 3 520 000 | 832 000 | 29 300 |
ISO 9 | (c) | (c) | (c) | 35 200 000 | 8 320 000 | 293 000 |
(c): The concentrations in these areas are too high to be classified in these particle sizes.
(d): Limits not specified due to very low concentrations that make sampling difficult.
(e): Sampling 5.0 µm particles in low classes (ISO 1 to 5) is not recommended due to losses in the sampling system.
(f): For ISO class 5, the descriptor M can be used for particles of 5.0 µm, but not for formal classification.
This table refers to the occupancy status (at rest or in operation) that must be agreed between the customer and the supplier.
ISO 1 to ISO 3 Extremely controlled environments ISO 4 to ISO 6 High precision applications ISO 7 and ISO 8 Most common in the pharmaceutical industry and medical devices ISO 9 Controlled environments with less demanding requirements
Contamination control equipment and consumables
Choosing the right equipment and consumables is fundamental to maintaining the integrity of the controlled environment.
Main categories:
- Cleanroom gloves
Developed to minimize particle release and ensure protection
- Specialized clothing
Suits, caps, masks and shoe covers
- Wipes and consumables
Cleaning materials with low fiber release
- Sterile PPE
Specific solutions for the most demanding environments
Proper selection contributes directly to reducing the risk of contamination and compliance with applicable standards.
Simplified protection with Ansell Guardian
Ansell Guardian is a service that makes it possible to analyze, select and optimize the use of personal protective equipment, including solutions adapted to clean room environments.
Based on a data-driven approach, it assesses the risks, processes and products in use, identifying concrete opportunities for improvement in terms of protection, operational efficiency and cost control. This service includes a detailed assessment of the risks and needs of the environment, as well as an analysis of the PPE currently in use, making it possible to develop personalized recommendations and support the implementation of more efficient solutions.
As a result, it contributes to reducing the risk of contamination and human error, promotes greater operational efficiency and makes it possible to optimize the associated costs, while ensuring better alignment with regulatory requirements. This approach is especially relevant in cleanrooms, where the inappropriate choice of equipment can compromise the entire controlled environment.
Good practices and benefits of PPE
in critical environments
Compliance with protocols
Frequent and controlled sanitization
Limiting unnecessary movements
Constant monitoring of the environment
Benefits for companies
Reduced risk of contamination
Increased product quality and consistency
Compliance with regulatory requirements
Building trust with clients and partners
FAQS - PPE for cleanrooms and controlled environments
What PPE is used in clean rooms?
These include technical clothing (full suits, gowns), gloves, masks, caps and footwear protection. The selection must guarantee low particle release and compatibility with the classification level of the room.
What is the difference between sterile and non-sterile PPE?
Sterilized PPE goes through controlled processes to eliminate microorganisms and is used in critical environments, such as ISO 5 rooms. Non-sterilized PPE is suitable for less demanding levels, where microbiological control is not as strict.
Is cleanroom PPE always disposable?
No. There are disposable and reusable solutions. The choice depends on the level of control required, the frequency of use and the validation and washing processes available.
How to choose the right PPE for clean rooms?
The selection must take into account the ISO classification of the room, the type of process, the risk of contamination and the compatibility of the materials with the environment. The wrong choice can compromise the effectiveness of particle control.
Does PPE for clean rooms meet specific standards?
Yes. They must be aligned with requirements for controlled environments, such as the ISO 14644ensuring adequate levels of particle control and material performance.
Is it necessary to wear full protection in clean rooms?
It depends on the classification level. In more critical environments, such as ISO 5 or ISO 6, integral protection is required to minimize the release of particles by the operator.
What are the main sources of contamination in clean rooms?
Operators are one of the biggest sources, through their skin, hair and clothing. Poorly controlled equipment, materials and airflow also contribute to contamination.
What is the difference between cleanroom clothing and conventional industrial PPE?
Cleanroom clothing is designed to minimize the release of particles and fibers, unlike conventional industrial clothing, which focuses primarily on protecting the wearer.
How often should PPE be changed in clean rooms?
It depends on the type of PPE, the criticality of the environment and internal procedures. In many cases, disposable PPE is only used once to avoid cross-contamination.
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Solutions Life Sciences / Cleanroom
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