Pharmaceutical Clean Room Classification | Most recent update of 14644

Definition:

A Cleanroom is a facility which provides a dust and contamination free environment necessary for the manufacturing of contamination sensitive products.

Cleanroom purpose:

The manufacturing of certain products and related processes and procedures require clean and sanitized space to ensure the product quality, efficacy, and safety.

Industries That Utilize Cleanroom: Pharmaceutical Clean Room Classification 

·       Pharmaceutical

·       Biotechnology

·       Life Sciences

·       Food Manufacturing

·       Healthcare

·       Automotive industry

·       Electronic Part Production

The most recent update of ISO 14644 provide following information on Pharmaceutical Clean Room Classification 

In this update of Pharmaceutical Clean Room Classification  you can see one major change for class 5 as you can see from the above image file.

Cleanrooms Specifications:

A Cleanroom is an enclosed area in which airborne particulates, contaminants, and pollutants are kept under or within the strict limits.

Cleanroom specifications are predefined for particulate matters and it is achieved by minimizing the introduction, generation and retention of contaminants in the area. The apparatus used must also be contaminant free.

Other parameters i.e. temperature, humidity, pressure, light, airflow are also controlled accordingly.

Cleanrooms Installation:

Cleanroom installation requires a clean zone.  Along with its associated structures, it requires an air-treatment system and other specifications and services.

Cleanrooms Classifications:

Cleanrooms are classified into different categories based on the level of cleanliness in order to produce quality products. The number of particles allowed is measured in one cubic foot of air.

The particulate cleanliness of air is defined based on 3 states:

·       As-built

·       At rest

·       Operational

ISO classification system:

This classifies cleanroom into different classes: ISO 1 to ISO 9. Where 1 is the cleanest class and 9 is the dirtiest class. Class 7 and 8 are the most common

       The airborne particulate facilities are designed based on 

·      ISO Classification number, which is ISO N (N= 1, 2, 3, 4, 5, 6, 7, 8, 9)

·      Particle size (µm) and the quantity of particles per volume of air

·      Occupancy state

Designation Example: 
– ISO Class 4: Operational state; considered sizes: 0.2 µm (2370 particles/m3), 1 µm
(83 particles/m3)

Method to Control Airborne Environment:

·      Air Flow Principle: HEPA or ULPA filters are used to maintain particulate-free air.

·      Dilution: High Air Change rate

·      Isolation

PIC/S Classification:

1.     GRADE A: This includes the clean zone for high-risk operations like ampoules, vials, filling zone and aseptic preparations. Use the Laminar Air flow (LAF) system which ensures homogeneous airspeed of 0.45 m/s at the working station.

2.     GRADE B: For aseptic preparation and filling. This zone provides background environment for Grade A operations and other less-critical tasks.

3.     GRADE C: Use for the preparation and filing of less sensitive solutions.

4.     GRADE D: Preparation of products and washing of components for subsequent use.

Pharmaceutical Clean Area guidelines:

·      FDA guides to establish an automated monitoring system to detect the critical changes.

·      According to the FDA, air should flow from the higher cleanliness room to the lower one to prevent entrance of the contaminants.

·      All personnel and equipment must enter through airlocks.

·      The desired airflow should be maintained through appropriate filters.

·      There should be a separation of areas in the cleanroom during the manufacturing process based on the activities.

·      It is important to meet the “operational state” requirements, for that “at rest” state. Room should meet all the criteria, after every operation.

·      Cleanroom and clean area instruments must be monitored on regular basis to ensure the accuracy of the whole process. Risk analysis of different areas should be done based on the classification.
– Grade A: Require particle monitoring for full duration of critical preparations including instruments. The sampling method should be separate from zone protection; final product result consideration is required. 
– Grade B: Sample frequency is less as compared to Grade A, otherwise same.
– Grade C and D: Performance must be in accordance with the principles of quality risk management and depend on nature of operations carried out.

Cleanrooms Designs:

Control and Segregation Concept:

Cleanroom are often surrounded by further lower cleanliness areas which help in reducing the size of highest cleanliness zone. They help in managing the movement of persons and material in the entire adjacent cleanliness zone to reduce the chances of contamination and help to reduce the economic and the operational cost of process.

Read about particle count procedure here