ISO Class 7 Cleanroom Standards | Particulate, ACH ...

As highlighted by various sources, ISO Class 7 cleanrooms are meticulously designed to achieve specific cleanliness requirements, significantly impacting sectors such as pharmaceuticals, biotechnology, and medical device manufacturing. These cleanrooms utilize a combination of HEPA or ULPA-filtered air systems, ensuring a controlled environment conducive for critical operations. In this article, we will delve into the key considerations and standards associated with ISO 7 cleanroom design and construction, focusing on particulate counts, air changes per hour (ACH), and specialized equipment necessary for different applications.

ISO 7 Cleanroom Standards | ISO

ISO sets forth a collection of comprehensive international standards underlying various cleanroom operational aspects such as design, construction, and performance demands.

ISO -1 specifies air cleanliness levels, stipulating that an ISO 7 cleanroom must maintain fewer than 352,000 particles of size 0.5 μm or larger per cubic meter of air.

ISO -2 delves into monitoring requirements essential for ensuring continuous compliance, which is paramount in maintaining quality standards in sensitive cleanroom applications.

ISO -3 details testing methodologies designed to confirm compliance with ISO 7 parameters, involving tests for containment, airflow performance, and pressure differentials.

Moreover, ISO -4 defines the construction and design attributes necessary for ISO 7 cleanrooms, including specifications for HVAC systems and materials intended to minimize particle shedding. Lastly, ISO -5 outlines operational protocols that must be observed to uphold ISO 7 classification, covering aspects such as personnel training and cleaning procedures.

ISO 7 Cleanroom Definition

Under the ISO -1 framework, ISO 7 classifies air cleanliness based on airborne particle counts. To achieve ISO Class 7 certification, the cleanroom must observe these particle limits per cubic meter of air:

• 0.5 μm particles: Max 352,000
• 1.0 μm particles: Max 83,200
• 5.0 μm particles: Max 2,930

ISO 7 Cleanroom Air Changes

Air changes per hour (ACH) are crucial metrics that measure the effectiveness of cleanroom HVAC systems in exchanging contaminated air with HEPA-filtered air. Generally, ISO 7 cleanrooms require 60 to 90 air changes per hour, with many systems operating closer to the lower end of this spectrum.

ISO 7 Gowning Room Design

The inclusion of an independent gowning room within ISO 7 cleanrooms is common practice, facilitating the donning and doffing of cleanroom attire. This design minimizes the risk of contamination from personnel entering the cleanroom space.

Typically, gowning rooms are set at one ISO class higher than the production areas; thus, an ISO 7 cleanroom would likely have an accompanying gowning room with ISO Class 8 standards. Specific guidelines for these spaces are further detailed for facilities operating under USP chapters 797/800, emphasizing that buffer rooms meet at least ISO Class 7 air quality, while ante-rooms should be at least ISO Class 8.

ISO 7 Cleanroom Pass-Throughs & Gowning Equipment

Pass-through systems are vital in maintaining cleanliness while allowing for the seamless transfer of equipment and supplies into and from the cleanroom environment.

Terra's pass-through chambers utilize interlocking door designs, ensuring single-user access to prevent contamination and maintain controlled airflow between rooms with different pressures.

CleanMount® CleanSeam® Pass-Through Chambers feature streamlined internal designs that improve cleanability and reduce contaminant accumulation risks.

Terra also offers a comprehensive range of cleanroom-compliant equipment such as workstations, garment racks, and storage solutions tailored to enhance compliance throughout the gowning process. Our specialists are available to assist with configuring your gowning room to align with specific cleanliness and facility requirements.

ISO 7 Cleanroom Applications

Medical Device Packaging, Assembly, and Testing

ISO 7 cleanrooms are instrumental in the production of medical devices, sterile drug compounding, and related processes such as weighing and packaging pharmaceuticals and nutraceuticals.

ISO 7/Class 10,000 Hardwall Cleanrooms for Pharmaceutical and Biotechnology Research

These cleanroom configurations are pivotal in maintaining sterility and preventing contamination, particularly in pharmaceutical and biotechnology research environments.

ISO 7 Multi-Suite Cleanroom for Pharmaceutical Tablet and Capsule Packaging

ISO 7 multi-suite cleanrooms facilitate the packaging of pharmaceuticals with designs that easily integrate and adapt to existing facility layouts.

ISO 7/Class 10,000 Modular Hardwall Cleanroom for USP 797/800 Compounding Pharmacy

This modular cleanroom configuration meets strict regulations for pharmacy compounding, featuring robust, chemical-resistant materials and a positive-pressure airflow design.

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