An Overview of ISO 14644 Clean Room Classification

An Overview of ISO 14644 Clean Room Classification
All classes of clean rooms, airborn particles and formula to calculate the number of sampling locations.
The area having controlled airborne particle concentration is considered as the clean zone or clean room. These areas are constructed to minimize the introduction, generation, and retention of airborne particles in the area.

The concentration of particles depends on their diameter; hence the bigger particles will be less in number than the smaller particles in any clean room environment.

The airborne particles play a considerable role in aseptic processing because the viable particles i.e. bacteria, fungus etc. are associated with non-viable particles and may cause
contamination in pharmaceutical sterile preparations.

Classification of these areas are given in many guidelines but the base of all other guidelines is ISO i.e. ISO-14644-1. A proper classification is given in ISO with the formula which gives the concentration of airborne non-viable particles in any class.

Table 1 shows the different classes of clean rooms.

There are 9 classes of clean rooms in ISO but only ISO Class 5 to ISO Class 8 for 0.5 μm and 5.0 μm are applicable in pharmaceuticals. These numbers of particles are calculated for every class and for all particle sizes by the formula given below-

Where,
Cn =The maximum permitted concentration (in particles per cubic meter of air) of airborne which is rounded to the nearest whole number, using not more than three significant figures.
N = The ISO classification number, which shall be from 1 to 9.
D = The considered particle size, in micrometers i.e. 0.1 μm to 5.0 μm
0. 0.1 = A constant

Controlled areas are not only expensive to build but these are also more expensive to maintain. Following points should consider while designing the clean rooms.

1. Air supplied through HEPA filters with high air changes to dilute and remove the particles and microbial contamination generated by personnel and the machinery.

2. The area should be constructed in such a way that the particles should not be generated and should be clean easily. Usually the material like metal id used for walls and ceiling while the floor should be of Vinyl of Epoxy.

3. The operators and other supporting staff should wear the covering clothes like mask and gloves etc. to minimize the dispersion of particles and microbes in the area.

4. A positive should be maintained in the area to avoid the entrance of particles and contamination through the air.

Also see:Clean Rooms And Controlled Areas (Sterile Area)

Comments

Checklist for Audit in Sterile Area

Checklist for Audit in Sterile Area Checklist to verify the sterile manufacturing area before the audit. 1. Is there any SOP giving details for activity/ movement in the sterile area. 2. Verify the suitability of system for sanitization of hands. 3. Is there the SOP on entry-exit; gowning and de-gowning into the critical area available? 4. Verify the availability of following records: Air pressure differential Particulate monitoring Temperature Humidity Microbiological monitoring by settle plate 5. Are these records available and maintained as per SOPs? 6. Check the above mentioned individual records. Are the entries within specifications mentioned in SOP/ MTPs. 7. Is the controlled copy of MTP pertaining to monitoring by settle plate available to plant person? 8. Are the location for settle plates identified and the chart/ layout available with plant? 9. Are the following areas monitored for parameters mentioned in step 4: Air-lock to the critical ar...

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the FFS and BFS is to reduce the contamination by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...

Pharmaceutical Guidelines

Search This Blog