Introduction
Pharma equipment is cleaned after the completion of every batch, specifically after every product. Among all of these, its primary aim is product safety from cross-contamination and product mix-up. Regulatory bodies also thoroughly investigate the cleaning process due to their routine inspection.
What is meant by cleaning in pharmaceutical industry
Cleaning is a process that removes all visible and non-visible particles, contaminants, and microorganisms that can infect different pharma equipment parts, specifically during routine production. These contaminants also includes dirt and product residues. Some contaminants can be removed using simple accessories, such as a plain cloth, while some may require complex tools and cleaning agents. The selection of accessories, tools, and agents depends on the contamination types and is selected during validation studies.
The cleaning is performed according to the approved SOP, which describes all the steps in a cleaning process. The SOP is prepared by the relevant department and with the approval of the Quality department; the SOP is specific for specific equipment and cannot be used for equipment other than for which it has been prepared.
After cleaning , the equipment is verified for its effectiveness. It is performed through visual inspection and analytical methods.
In the visual method, a supervisor of the personnel who has performed the cleaning visually verifies the cleaning for any physical trace, residual, contaminated fluid, and others.
In the analytical method, laboratory instruments are used to verify the absence of any residual or contaminant by taking samples from the cleaned equipment.
Like other manufacturing processes, cleaning is also validated for its effectiveness. The cleaning validation is performed with appropriate frequency, & resources and proper documentation are generated.
Cleaning Records
Like all other processes in the pharma industry, records of equipment cleaning must be maintained, which are reviewed explicitly during their routine inspection.
For the United States, record keeping must follow FDA guidelines 21CFR 211.180 and 21CFR 211.182.
The 21CFR 211.182 is the cGMP for finished pharmaceuticals, and its subpart J Records and Reports, general requirements, describes general record-keeping guidelines related to the pharma industry.
The 21CFR 211.182 is the cGMP for finished pharmaceuticals, and its subpart, J Records and Reports, equipment cleaning and log, describes general record-keeping guidelines related to the pharma industry, and describes the records guidelines as per the following
A written record of equipment cleaning for each piece of equipment must be included in each equipment log.
If equipment is dedicated to a single product, individual equipment logs are not required and must be part of the batch record.
The person responsible for performing and checking cleaning shall initiate the logs chronologically.
How is equipment cleaned in the pharmaceutical industry?
Traditionally, the manual method was commonly used to clean the equipment. However, now automated cleaning is also becoming popular. Let's briefly discuss these.
Manual Cleaning
In manual cleaning, the equipment is dismantled from its place, transferred to the cleaning bay or area, and then cleaned using different tools and cleaning agents. If the equipment is large enough to be shifted to the cleaning area, the equipment is dismantled at its current place ( in the production area) and then cleaned.
Brushes, scrapers, buckets, and other tools are used during manual cleaning. This is a relatively simple method, where the efficiency of the cleaning process depends on the operator's performance and effectiveness. It includes pre-rinsing, using cleaning agents (or water), and finally, post-rinsing.
The disadvantage of manual cleaning is that it cannot be replicated due to inconsistencies related to human performance. Another disadvant...
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