Author: svs-arta

Basic requirements for clean rooms in pharmaceutical production

Cleanroom requirements for aseptic pharmaceutical and terminally sterilized pharmaceuticals differ. The filling / filling process (critical process) in the production of non-terminally sterilized pharmaceuticals requires a clean area “A” surrounded by a clean area of class “B” to minimize the risk of contamination of the finished product with particles and microorganisms.

For pharmaceutical products that undergo terminal sterilization, the “Rules for the organization of production and quality control of medicines” establish less stringent requirements. In particular, filling with terminally sterilized products can be carried out in a class C production environment, however, if there is an increased risk of contamination (if the filling operations are slow or the packages have a wide neck, or they need to be kept open for more than a few seconds before sealing), the filling is so the same should be carried out in a clean area of class A (but with an environment of at least class C).

What is the purpose of certification of clean rooms in the pharmaceutical industry?

In 2009, сommittee of Ukraine for Regulatory Policy and Entrepreneurship (State Committee for Entrepreneurship) approved Licensing Conditions for the implementation of economic activities for the production of medicines, wholesale, retail sale of medicines (Licensing Conditions). The production of medicines and pharmaceutical substances must be carried out in clean rooms with proven qualifications. In the production of medicines, the concept of “sterility” is of particular importance, meaning “the absence of living microorganisms”. Technological operations in the production of drugs, both terminally sterilized and produced under aseptic conditions must be carried out in clean rooms or clean areas to ensure sterility in pharmaceutical production.

MEDICAL CLEANROOMS

Medical cleanrooms are vital for the work of finding medical solutions, developing vaccines and treatments through pharmacological products, and manufacturing life-saving medical devices. Three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms. The cleanroom design for each type will differ depending on the goals of the facility and its cleanroom classification requirements. Let’s take a closer look at these three types of medical cleanrooms, and how they differ in their applications, classifications, and cleanroom design.

MEDICAL RESEARCH CLEANROOMS

Medical research cleanrooms are used in the pursuit of medical understanding, research and experimentation, and the development of treatments. Medical research cleanrooms are often required to be biosafe, and have extra safeguards in place to protect employees and their important work from potential biosecurity risks.

The cleanroom environment must be highly sterile. Medical research cleanrooms usually fall within ISO 14644-1 Class 5-7. The rigorousness of the standard is dictated by the risk level of contaminants to cleanroom operations and safety. For example, for research involving blood or stem cells, an ISO Class 5 cleanroom environment is likely necessary. This means the cleanroom must have a powerful filtration system in place, with allowed particle count of fewer than 3,520 particles half a micron or larger.

Medical research applications working with infectious or toxic fumes or substances often require negative pressure cleanrooms. This added safeguard keeps contaminants from inside the cleanroom from escaping where they could cause harm to those outside the cleanroom environment. Whether for the uses of cancer research, the study of infectious diseases and viruses, or the pursuit of potent and effective vaccinations, medical research cleanrooms are fully equipped with all the specialized equipment, safe storage, and ergonomic furniture researchers need to do their jobs comfortably and effectively. Medical research cleanrooms are usually designed with CBC-ARTA which can meet even the most stringent classifications these types of medical cleanrooms may require, and are highly modifiable to any application’s unique needs.

MEDICAL DEVICE CLEANROOMS

Medical devices are specialized products used to diagnose, treat, and cure patients. Unlike pharmaceutical products, medical devices are not metabolized. Instead, they can be used internally and externally as a tool by medical professionals, or even implanted for a long-term solution. Because they come into contact with tissues and membranes, medical devices must be contaminant-free or able to be thoroughly sanitized to prevent the possibility of infection or other risks. For this reason, the production, assembly, and packaging of medical devices requires a controlled cleanroom environment, validated and monitored by stringent requirements and quality control.
The different stages of medical device production, assembly, and packaging have different cleanliness requirements, and often fall under separate classifications. For example, most medical device manufacturing cleanrooms must comply with ISO Class 5-8 standards.
More specifically, medical device cleanrooms manufacturing non-critical and semi-critical devices fall in the ISO Class 7-8 range, while devices with critical disinfection levels (like surgical equipment and implanted devices) require the cleanest environments and must comply with ISO Class 5 or greater. Essentially, the stringency of requirements increases as device part sizes become smaller and more.
Medical device packaging cleanrooms, while still very closely monitored to prevent contamination, generally operate within ISO Class 7-8 standards.
The best cleanroom type for medical device manufacturing and packaging is a HardWall cleanroom. This cleanroom type is able to comply with strict classification requirements and maintain a stable, contaminant-free environment throughout all stages of device production.

PHARMACEUTICAL CLEANROOMS

Pharmaceutical cleanrooms are used to develop chemical treatments and cures to improve health and save lives. In the development and testing of pharmaceuticals, even the slightest contamination could have serious consequences on medical study results or treatment efficiency, and could even lead to life-threatening consequences. Because of this, the pharmaceutical industry is subject to heavy regulation.

Pharmaceutical cleanrooms often require varying levels of cleanliness depending on the type of substances, chemicals, and procedures involved in their operation. The minimum standard for pharmaceutical cleanrooms is generally ISO 7 with progressing needs of ISO 5 or more, which requires 240-600 air changes per hour and 35-70 percent ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter.

Pharmaceutical cleanrooms are also governed by additional regulations by US Pharmacopeia, or USP Standards. USP standards prescribe layout options according to the optimal airflow patterns, cleanroom organization, operator techniques, and sanitation levels of each standard.
Due to the high level of control needed in a pharmaceutical cleanroom, HardWall cleanrooms are the obvious solution. Able to maintain strict environmental standards and eliminate error caused by temperature, humidity, or contamination, SVS-ARTA cleanrooms offer a reliable structure to any medical cleanroom design.
These three types of medical cleanrooms are vital and valuable investments to businesses pursuing research or creating and preparing compounds and devices to improve health and save lives. Important work in the healthcare industry merits a high-performing medical cleanroom to keep projects and employees protected.

From pharmaceutical development to medical device manufacturing and packaging, Angstrom Technology designs, builds, and installs medical cleanrooms for any classification standard. If you’re ready to start designing your new cleanroom, get in touch with SVS-ARTA professional team today.