A good manufacturing practice (GMP) cleanroom is a controlled environment for manufacturing processes that adhere to specific GMP regulations. The Food and Drug Administration enforces these regulations for certain facilities in the United States to ensure products meet consistency and quality standards. GMP cleanrooms minimize viable and nonviable particle contamination.
These environments are critical for industries like health care, pharmaceutical production and similar landscapes that demand stringent product and process quality standards. This guide to GMP cleanrooms explores cleanroom classification, applications, compliance requirements and design considerations for simple implementation.
GMP standards differ from other quality standards. They’re similar to International Organization for Standardization (ISO) standards but are more directed toward medical applications. Like the classes of ISO standards, GMP standards use grades to distinguish different environmental regulations and allowances.
GMP cleanroom grades refer to the cleanliness level of the environment. Each grade depicts the particle limits necessary to meet each level. The four grades include:
Grade A: High-risk applications needing stringent environmental control need Grade A GMP cleanrooms. These zones are equivalent to ISO Class 5 in operation and at rest. This grade prohibits sinks and drains.
Grade B: This grade is equivalent to ISO Class 7 in operation but ISO Class 5 at rest. Grade B GMP cleanrooms typically have particle monitoring alarm systems to indicate if levels exceed required levels.
Grade C: Less critical operations may use Grade C GMP cleanrooms. These zones are equivalent to ISO 8 in operation and ISO 7 at rest. Quality risk management impacts monitoring needs.
Grade D: Grade D cleanrooms reflect the least intense requirements for GMP environments. These zones are equivalent to ISO 8 at rest but do not have a defined ISO equivalent when operating.
GMP Cleanroom Applications
Many industries require GMP cleanrooms for specific applications. Here are just a few examples of how GMP cleanrooms can be used in various sectors:
Pharmaceutical manufacturing: Cleanrooms for pharmaceutical manufacturing enable applications related to supplements or medicines. Compounding, testing, researching and packaging may occur in a GMP pharmaceutical cleanroom. Utilizing these environments enables teams to protect patient safety and ensure repeatable, effective and accurate results.
Medical device manufacturing: Injectables, imaging equipment and surgical supplies are examples of medical device manufacturing that require a GMP cleanroom. Consumables and devices to aid consumption must be regulated because they can affect patient health through contact with membranes and tissues.
Cell and gene therapy: Regenerative medicine, such as cell and gene therapy, involves injecting intact, live cells into patients to cure or treat conditions or diseases. Gene therapy may alter how cells produce a single protein or group of proteins. The nature of these sensitive applications requires environments with GMP compliance to ensure patient safety and product efficacy.
Radiopharmaceutical manufacturing: Radiopharmaceutical applications may include detecting health issues through diagnostic agents or creating treatments for serious diseases. In this industry, cleanrooms require specific design considerations because exposure to drugs or compounds with these isotopes can cause adverse health outcomes for cleanroom operators.
Food and beverage: Applications involving packaging, manufacturing, testing and similar food and beverage tasks require GMP compliance. This industry handles consumables, making it essential to adhere to GMP standards to protect consumer safety.
Flush design and finish: GMP cleanrooms should have flush designs for all doors, windows, walls and ceilings. Flush designs make it easier to control contaminant levels, and a lack of edges allows for streamlined cleaning and sanitation.
Environmental monitoring: Your cleanroom will require a system that adheres to GMP guidelines for environmental and microbiological monitoring. Grade A and B cleanrooms must feature an alarm to indicate if levels exceed allowable limits. You should also be able to monitor and control airflow, pressure and humidity.
Airlocks and pass-throughs: Airlocks connect two distinct areas with varying standard requirements with two or more doors. For example, if you have a Grade B area and a Grade C area, airlocks will restrict direct airflow between the compartments. Pass-throughs enable the transfer of materials from one zone to another between an installed cabinet.
Interlocking systems: Airlocks, pass-throughs and entry points must have interlocking systems to meet GMP compliance. These systems prevent multiple doors or access points from opening at the same time. Interlocking systems prevent airborne particles in a wind corridor from moving to the cleaner side of an environment and minimize pressure losses.
HVAC systems: Cleanrooms require clean air and ventilation. Heating, ventilation and air conditioning (HVAC) systems can improve indoor air quality, ensure proper airflow and control air changes per hour. A cleanroom HVAC system can also remove excess moisture and control pressure differentials.
Sinks and drains: Sinks or drains can’t be installed in a Grade A or Grade B cleanroom. However, you can add these fixtures in anterooms or gowning areas. Consider the location for these fixtures for seamless operations and establish ways to prevent backflow through water seals and traps for lower-grade zones.
GMP Compliance for Cleanrooms
Depending on your industry and applications, you may need to adhere to various regulations and standards when setting up and using your cleanroom. Some of the most common GMP cleanroom standards to note include:
United States Pharmacopeia (USP) standards: These standards are generally specific to pharmaceutical applications. USP standards aim to protect worker and consumer safety in the consumption, development and distribution of medicines.
American Society for Testing and Materials (ASTM) standards: ASTM standards often refer to industrial and manufacturing sectors. They ensure quality control by regulating cleanroom processes to ensure high-quality, consistent results.
ISO standards: ISO standards such as ISO 14644-1 regulate contamination levels by considering air change rates, ceiling coverage percentage, maximum allowed particles and airflow velocity.
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When your applications require a GMP cleanroom, trust our experts to find the right solution. Request a free quote today to discover how we can help your business.