Skip to main content

Criteria for Selection of Clean Room Garments in Pharmaceuticals

Criteria for Selection of Clean Room Garments in Pharmaceuticals

Clean room must be protracted form all types of contamination. Clean room clothing is the main source of this contamination that can be eliminated by using of appropriate cloths.

A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, as well as clothing that enter the GMP clean room, should be of the highest quality to prevent bringing in any contaminants from other places. 

Therefore, when selecting the cleanroom garments, the quality of the garment, as well as its cost, should be the key considerations. Employees also need a flexible garment that will not prevent them to work effectively in the cleanroom. The following factors need to be considered when choosing the right garment for the cleanroom in the pharmaceutical industry.

The Class of the Cleanroom
The class of the cleanroom is one of the important factors that must be considered when choosing the garment for the cleanroom. Those cleanrooms that are of higher cleanliness always require a garment that covers the entire body to minimize the chances of contamination in the cleanroom. For example, employees working in the ISO class 5 cleanrooms need to wear not only the coveralls but also hoods and boots as well as masks and gloves.

Type of Cleanroom
The type of cleanroom should also be a factor to consider when choosing sterile area clothing for pharmaceuticals. In a cleanroom that produces sensitive products such as vaccines under a sterile condition, employees should wear a garment whose fabric is resistant to multiple cycles when sterilizing the manufacturing garments.

Static Charge
Since a cleanroom is supposed to be sterile and free from other contaminants at all times, static electricity is very crucial when it comes to how to choose cleanroom clothing. When an individual wears a garment that has a higher s tatic electricity, contaminants such as bacteria can get attracted to the garment through static electricity which in turn will contaminate the cleanroom. Therefore, a garment for cleanroom should be manufactured from a material that is static dissipative with a resistance range of 106-108 Ohms.

Garment Changes
There are different types of cleanrooms with different s tandard operating procedures. For example, some cleanrooms require that employees change their garments per week whereas others only require using the same garment for quite some time. Therefore, cleanrooms that require a change of 20 garments per week should choose reusable launderable garments.

Compatibility
When choosing the garment for the cleanroom in pharmaceuticals, then you should choose a garment that is compatible with other accessories such as gloves and masks as well as footwear.

Visitors
The number of visitors that visit the GMP clean room on a daily basis should also be a key factor to consider when it comes to how to choose cleanroom clothing. If the cleanroom gets many visitors on a daily basis, then you should go for the launderable garments. And if the cleanroom receives few visitors, it will be better to choose the disposable garments since it will be economical. You may choose disposable garments for visitors and reusable or washable garments for the employees.
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