Skip to main content

Different Types of Diffusers Used in Pharmaceutical Clean Rooms (Controlled Area)

Different Types of Diffusers Used in Pharmaceutical Clean Rooms (Controlled Area)

Know about different types of air diffusers used in HVAC systems in pharmaceuticals to disperse the clean air in cleanrooms.

Air diffusers are used in clean rooms and other controlled areas to distribute the clean air passed through the HEPA filters. Diffusers are the important part of the HVAC system and play a vital role in the maintenance of the classified area.

The number of diffusers in a room depends upon the volume of the area, size of diffusers and required air changes per hour. Diffusers are mounted in the ceiling of the room to distribute the uniform air in the area and return risers should not be near the diffusers. Otherwise, air pockets will form that can increase the contamination level in the area. Place and type of diffusers to be used should be included in the HVAC system qualification.

Generally, three types of air diffusers are used in pharmaceutical industries.

  1. Induction Diffusers
  2. Perforated Plate Diffusers
  3. swirl Diffusers

Induction Diffusers: Induction diffusers are generally used in offices and therefore also called office type diffusers. These diffusers direct the air to flow in different directions.WHO does not recommend these types of diffusers to use in pharmaceutical processing areas because these diffusers mix the fresh air with the contaminated room air (see figure) and the air should be replaced with the fresh air to minimize the contamination. In the areas where dust is liberated it is important to replace the air containing dust with the fresh air.

Perforated Plate Diffusers: These are the WHO recommended and widely used diffusers in pharmaceutical industries. They allow the air to flow in all directions replacing the air containing dust and contamination with the fresh air from the supply.



Swirl Diffusers: These rotating diffusers are also recommended by the WHO which rotates during the fresh air supply allow distributing the fresh air throughout the area.

Labels:

Comments

Post a Comment

If you have any doubts, please let me know

Popular posts from this blog

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...
Post a Comment
Read more

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...
Post a Comment
Read more

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...
Post a Comment
Read more