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Cleanroom type according to EU GMP standard

What is the cleanliness level of the cleanroom?

Clean areas are controlled in terms of factors: the limit of particles in the air, the limit of infection, temperature, humidity, light, and the pressure difference between rooms to help ensure quality products and safe for users.

The cleanliness level of a pharmaceutical or functional food manufacturing facility is regulated and established by each stage of production (dispensing, packaging, labeling) and for each form of the drug (tablets, tablets, etc.), capsules, solution for infusion, solution for eye drops, etc.)

4 GMP factory cleanliness level

To achieve clean air class A, B, C, and D, standard cleanliness level GMP, the number of air exchanges must match the room’s size, equipment, and the number of employees present. Typically, the number of air exchanges is at

  • Level D: 20 times
  • Level C: 30 times
  • Level B: 40 times
  • Level A: 60 times

HEPA filters must be leak tested according to ISO 146444-3, with a recommended frequency of every 6 – 12 months to ensure that the filter media, frame, and internal joints are not exposed, leakage.

4 levels of cleanliness in a GMP plant (A, B, C, D) according to the maximum amount of particles allowed in the air:

The maximum allowable number of particles greater than or equal to the size in the table per m³
  • Level A: Equivalent to ISO 4.8 calculated according to the particle size limit ≥ 5.0µm. A continuous measuring system should monitor the number of particles in a Class A clean zone.
  • Level B: Equivalent to ISO 5, is an adjacent environment for an A-class area.
  • Level C: ISO 7 equivalent idle state, ISO 8 equivalent operating state.
  • Level D: Clean class has the lowest purity.

Particle count was determined using an airborne particle counter. The sample volume should not be less than 1m³, and the minimum sampling time is 1 minute.

A portable particle counter with a short sampling tube should be used to grade cleanliness levels to avoid the loss of particles ≥5.0 µm in size.

4 levels of cleanliness in GMP factory (A, B, C, D) according to the particle limit:

Areas with class A-D must be controlled for microbiological cleanliness in the operating state. When aseptic procedures are carried out, the microbial examination should be performed regularly with methods such as agar plate placement, air sampling, and surface sampling (e.g., smears and spread agar plates).

Appropriate warning and action limits should be set for particle and microbiological monitoring results. If these limits are exceeded, operating procedures should describe corrective actions.

Levels of cleanliness in sterile drug manufacturing

– Level A: Local areas for high-risk operations, such as vial closure and aseptic sealing. (Created by a unidirectional air blower system, with a speed of 0.36 – 0.54 m/s at a specified location 15 – 30 cm below the final filter or air distribution system)

– Level B: This level is the background medium for the A class zone in the final sterile preparation and bottling.

– Levels C and D: Clean areas for performing less critical steps in producing sterile products or conducting activities to which the product is not directly exposed.

The four levels in GMP plant that need to be correctly established and defined are essential in drug manufacturing. It helps to ensure product quality and user safety; any defect may reduce the quality of the finished product.

GMP factory cleanliness levels

Enterprises must comply with these standards to ensure the research and production process. According to the regulations of the World Health Organization, EU GMP, FDA, and PICs standards, there are 4 levels of cleanliness which are named in the order A, B, C, and D.

Explanation of cleanliness levels in GMP

(a): To achieve cleanliness, class B, C, and D – also involves the number of air exchanges. There are also factors in the size of the room, equipment, and personnel present. The air supply system in the cleanroom must be equipped with a HEPA filter. And they are adapted to suit cleanliness grades A, B, and C.

(b): Shows the maximum number of dust particles in the table according to GMP-EU. They are equivalent to US FDA and ISO standards. For example, cleanliness grades A and B are equal to FDA cleanliness class 100 M3.5 and equivalent to ISO grade 5. Level C is equivalent to cleanliness class 10,000, M5.5, and ISO 7. Class D will be roughly similar to class 100,000 M6.5 and ISO 8.

(c): These are known requirements and limitations for this area. They depend on the nature of the operations performed.

(d): Represents the conversion time, specifically from the active state to the stopped state. The number of particles measured in the active state must return to the stationary state. Usually, the recommendation will take 15-20 minutes.

(e) The need to build a class A, B, C or D cleanroom depends on the type of product the enterprise produces and each production stage. For example, conventional tablet products would be manufactured in a Class D environment. This is specified in the annexes in the GMP.

GMPNetwork.EU with more than 100 experts in Europe and around the world in the field of GMP consulting for the pharmaceutical and medical device industries according to European standards (EMA). We support our customers throughout the complete project lifecycle, from the point of project definition, through the implementation and maintenance and improvement of the quality system. Contact our experts for detailed consultation.

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