Hygienic garments for pharma manufacturing

Proper hygiene is essential in the pharmaceutical industry to prevent contamination and ensure the quality of medicinal products. There are four key areas to focus on: production hygiene, personnel hygiene, plant and surface disinfection and performance monitoring. Personnel hygiene starts with the right kind of garment, writes Ramdev Agarwal, Director, Pharma Sales, Lindström India.

Despite the measures taken to maintain hygiene in pharma production facilities, equipment, raw materials and product packaging, one of the primary sources of contamination is human beings. Using appropriate and hygienic and compliant garments is crucial in maintaining high standards of safety of products which ultimately ensures the wellbeing of end consumers. Here is how it can be done:

• Implement the use of hygienic and compliant garments in specified work areas such as critical production area and packaging area.
• Make sure there are always compliant and hygienic garments available in sufficient numbers. This should also include caps for hair and snoods for moustaches and beards.
• Provide education and training on the importance of hygiene and the proper gowning practices.

Focus on the laundry process

It should be done only by a professional and approved partner or an in-house facility conforming to regulatory norms that validates the entire process. The following measures must be taken to ensure the highest standards of hygiene in workwear laundering:

• Validated washing confirming EN14065 and cGMP standards
• Garments should be washed in recommended environment following ISO standards
• Validated microbial and particulate decontamination process
• Provide clean clothing in a bag to prevent cross contamination.

The importance of laundries in pharma

The industry-wide Current Good Manufacturing Practices (cGMP) ensure that products are manufactured and controlled according to quality standards. For garments, this means that all items must be accounted for at all times.

We need to be able to view and validate the entire life cycle of the garment. At Lindström, we use smart digital technology to provide companies with an item-level audit trail. The data shows us how long the garment has been used and when and where in our service cycle it has been scanned.

However, the data accumulated by the process is used for more than compliance purposes. When it’s crunched and analysed, it tells both Lindström and the customer a great deal about the flow of the products and gives clues on how to optimise the process.