The Difference Between Cleanchamber Testing and Climatic Testing - FDM

On these pages we often talk about climate testing, highlighting the extremely high manufacturing standards that most companies adhere to in order to provide safe and reliable products and services.

However, climate chambers and environmental testing are only part of the story.

Cleanchamber testing is essential for many industries, and in the following article, we'll explore what it consists of, what it's used for, and how it differs from climate testing.

What is the Clean Chamber Test?

Cleanchamber testing is a fundamental manufacturing practice in many industries. This process involves the careful evaluation of materials and products in a controlled environment to ensure maximum purity and minimize the risk of contamination. At the heart of the testing is a laboratory facility called a "cleanchamber."

A cleanchamber is defined as a sealed and isolated environment in which the concentration of particles is carefully monitored and maintained at very low levels.

These environmental conditions are necessary in the production process of various industries, let's see which ones.

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What is the Clean Chamber Test for?

The industries involved in cleanchamber testing are very similar to those we encounter on these pages when we talk about environmental testing, underscoring the similarity of objectives of the two procedures.

Here are the main ones:

Pharmaceutical Industry: Cleanchamber testing is essential in the manufacturing of drugs and medical devices, where purity is vital to avoid contamination and ensure patient safety.

Food Industry: In food production, the cleanchamber is used to preserve the quality and hygiene of products, minimizing the risk of microbiological contamination.

Industry Aerospace: Industries like aerospace require a controlled environment for the production of components and systems that must operate under extreme conditions. A cleanchamber ensures that these elements are free of particles that could compromise performance.

Electronics Industry: In the electronics industry, cleanchamber testing is vital to ensure the purity of the environment in which microchips and electronic devices are produced. Minimizing particle counts is essential to prevent component defects.

Clean Chamber Testing Requirements

To ensure maximum safety and reliability, cleanchamber requirements are defined by internationally recognized bodies.

The most important for cleanchambers is the ISO, International Organization for Standardization.

ISO 14644-1 provides clear guidance on the maximum number of particles allowed in a given volume of air. Within the standard, cleanchambers are classified hierarchicallybased on the cleanliness they can guarantee. For example, a cleanchamber classified as ISO 5 allows fewer than 3,520 particles with a diameter of ≥0.5 microns per cubic meter of air.

These stringent standards ensure that the environment complies with the specific needs of the industry involved, ensuring maximum purity and minimizing the risk of contamination.

Differences between Clean Chamber Testing and Climatic Chamber Testing

Cleanchamber testing and climatic testing have many similarities because they involve controlled manipulation of the environment and are essential in the same industries to ensure safety and efficiency. However, it's important to distinguish between cleanchamber testing and climatic chamber testing.

Cleanchamber testing focuses on particle reduction and contamination prevention and is primarily performed during production.

Climatic tests, on the other hand, simulate specific climatic conditions, such as temperature and humidity, to evaluate the behavior of materials in different environmental conditions and intervene at a later stage, to test prototypes already produced.

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The FDM Climate Chamber

We've seen that in today's world, manufacturers are required to ensure extremely high standards of safety and efficiency. Cleanchamber and climatic chamber testing meet this requirement.

For over 70 years, FDM Environment Makers has been designing technologically advanced climate chambers for companies, universities and research institutes.

Here you can see our models.

For any further questions or concerns, please do not hesitate to contact us.

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Reference Standards

ISO 14644-1 — Cleanchambers and associated controlled environments: Classification of air cleanliness by particle concentration, ISO classes 1-9.
ISO 14644-2 — Monitoring to provide evidence of cleanchamber performance related to air cleanliness by particle concentration.
ISO 14698 — Cleanchambers: Biocontamination control, principles, methods and requirements for biocontamination management.
IEC 60068 series — Environmental testing: series of climatic tests applicable when cleanchamber and integrated test chamber.
VDI 2083 — Cleanchamber technology: German reference standard for cleanchambers in the pharmaceutical, microelectronics, and space sectors.
USP 797 — Pharmaceutical Compounding: Sterile Preparations, US Pharmacopoeia requirements for sterile compounding in cleanchambers.

Authoritative Sources

ISO – International Organization for Standardization. Maintains the ISO 14644 series, the global reference for cleanchamber classification.
VDI – Verein Deutscher Ingenieure. A German technical organization, it publishes a very detailed VDI 2083 on cleanchamber technology.
USP – United States Pharmacopeia. Publishes USP 797/800 chapters for sterile compounding and hazardous drugs.

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Cleanchamber vs. Climate Testing Frequently Asked Questions

Cleanchamber and climatic chamber: what's the difference?

The cleanchamber controls the concentration of airborne particles according to ISO 14644-1 classes: ISO 5 ( A climatic chamber controls temperature, relative humidity, and pressure according to IEC 60068 or applicable standards. The objective is to qualify the product under thermal/hygrometric stress. The two functions are complementary and often combined in hybrid chambers where cleanchamber and climatic testing coexist: semiconductor burn-in in a class 7 cleanchamber, MEMS qualification, and cell therapy stability in a GMP cleanchamber. Hybrid design requires HEPA/ULPA HVAC integration with T/RH, ESD antistatic floors compatible with cleanchamber cleaning, and materials that do not release particles under extreme thermal cycling.

How does the pressure cascade work?

The pressure cascade is the fundamental principle for contamination containment: higher-cleanliness environments are maintained at positive pressure compared to less clean ones, forcing airflow from the clean area to the contaminated one. Typical values: +15 Pa between ISO 5 and ISO 7, +10 Pa between ISO 7 and ISO 8, +5 Pa between ISO 8 and non-classified. For pathogen containment or OEB 4-5 (cytotoxic, hormone) containment, the cascade is reversed: the handling environment is maintained at negative pressure compared to the external corridors to prevent the escape of contaminated aerosols. Monitoring is performed with differential pressure sensors in airlocks, continuous recording, and alarms for deviations > +/- 20% of the setpoint. The airlocks (MAL material airlock, PAL personnel airlock) implement cascades with double interlocking doors and air exchanges of 20-40 volumes/h for in-transit decontamination. Cascade management is a critical part of the Contamination Control Strategy GMP Annex 1 2022.

What gowning protocols for ISO 7?

The gowning procedure for ISO 7 cleanchambers (equivalent to Grade B in EU pharmacies) requires a rigorous sequence in a dedicated airlock: (1) grey zone entrance with hand washing, jewelry removal, shoe sanitization; (2 ) disposable TNT overshoes before entering the white zone; (3) full- face hood with hair collection; (4) N95 or higher face mask ; (5) one-piece coverall in sealed, low-shedding material (Tyvek, SMS polypropylene), zipped up to the neck; (6) high overboots over the suit; (7) double pair of sterile gloves with internal frame (latex or nitrile); (8) final sanitization of gloves with 70% IPA before access. The sequence lasts 5-8 minutes and requires full-body mirrors for self-checking. GMP personal training requires annual gowning qualification with particle count on the newly dressed garment (< 10 particles >= 0.5 um per m3 emission measured at 30 cm). USP 797 calls for similar requirements for sterile compounding USP Chapter 797-800.

Cleanchamber integration + thermal stress?

Hybrid climatic-cleanchamber chambers have specific applications. (1) Pharma stability ICH Q1A : ISO 8 cleanchamber with 25/60, 30/65, 40/75 climatic cabinets certified OQ/PQ for long-term studies of sterile formulations. (2) Cell therapy GMP : CO2 incubators inside ISO 7 cleanchamber with integrated IQ/OQ/PQ qualification for cell expansion/differentiation compliant with Annex 1 and FDA 21 CFR 1271. (3) Semiconductor reliability : HAST/temperature cycling in ISO 5 cleanchamber to prevent particle ingress during chamber opening. (4) Satellite thermal vacuum : combined chamber vacuum 1e-6 mbar + ISO 5 cleanchamber + thermal cycling -180 / +150 C for aerospace qualification. Technical challenges: (a) chamber internal materials must be cleanchamber-compatible (electropolished SS 316L, no releasing plastics); (b) HVAC HEPA must tolerate test temperature ramps; (c) instrument passages with high tightness; (d) validated post-test cleaning procedures to restore classification. The cost of a hybrid ISO 7 + climatic chamber is 3-5x that of separate chambers but guarantees performance that cannot be achieved otherwise.