Cleanroom Classification

  • 17, 09, 2019

Classification of cleanroom
Clean rooms in the pharma industry are arias which are specially designed to reduce and eliminate, particulate and microbial contamination in environment in aria used for manufacturing of pharmaceutical dosage forms, especially parenteral dosage forms which are required to be injected directly into body and blood stream are required to be free from viable microbial contamination as well as comply with the requirement of particulate matter present in addition to the requirement of absence of pyrogen. Controlling particle count in air supplied to manufacturing aria is achieved by filtering air entering inside through high-efficiency particulate filters which are capable of removing 99.997 % of particles from the air in rage of 0.3 micron and more. There are many techniques combined together to achieve the required level of cleanness like more is the volume of air filtered per unit time (per hour) more is the cleanness of cleanroom. ULFA filters are used to remove lower size particles.

Particulate matter are carrier of microorganisms hence reducing particle count directly reduces microbial contamination.

Requirements of or classifications of clean rooms in pharma manufacturing unit where sterile dosage forms are being manufactured are laid down by various agencies worldwide of which following are the important one.

Guidelines used worldwide to classify clean rooms in the pharma industry.
1) US Federal standards in good manufacturing practices guidelines in 21 CFR Part 210 211.
2) British Standards for cleanroom classification. BS 5295
3) European Union standards as described in the Guide for good manufacturing practices for medicinal products manufactured for sale in Europe.
4) ISO 14644-1 Standards.

We have given below in detail major requirements of each guideline, and their advantages.

1. United states Federal Standards 209E.
Cleanroom are classified as class 10 to 10000000, read below in detail.
These guidelines also classify clean room aria as 1) Controlled aria clean room 2) Critical aria.
Controlled area is used for compounding, and manufacturing process where in final product is made sterile in later stage, by terminal or filtration sterilisation( Class 1000, 10000). While critical aria is an aria where in products is exposed to external environment hence this environment must prevent contamination of product, (Class 100), Microbial count requirements as per US Federal regulation.
Critical area:  Not more that 0.1 colony forming units per cubic foot.
Controlled area: Not more that 2.5 colony forming units per cubic foot.

2. European Community Guidelines.
 Clean rooms are classified as
1) Class A --- At rest Particle count NMT 3500 particles of 0.5micron and above in cubic meter, at Operation 3500 particles of 0.5micron and above in cubic meter ( Equivalent to Class 100 , Laminar airflow bench)
2) Class B equivalent to Class 1000
3) Class C equivalent to Class 10000
4) Class D. equivalent to Class 100000
EU guidelines require that clean room meets standards in operation and as well as at rest.
It also requires that particle count measurement should be done within one foot distance of working point.

Regulatory requirements of a clean room in pharmaceutical

High-Efficiency Particulate Air filter, A velocity of 0.45 meters/second (90 feet per minute) has generally been established, with a range of plus or minus 20 percent around the set point. Higher velocities may be appropriate in operations generating high levels of particulates.

Two cleanroom or clean areas are of particular importance to sterile drug product quality: the critical area and the supporting clean areas associated with it.
EU guidelines require that clean room meets standards in operation and as well as at rest.
It also requires that particle count measurement should be done within one foot distance of working point.

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