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Cleaning specification, no doubt, is bound and defined in parity with the application, location and organization. However, it turns critical when it is outcome-oriented, especially in the pharma segment, requiring cleaning validation during preparation, processing and post production stages. Clean India Journal takes a peek into this specialized cleaning procedure.

IN PHARMA production, cleaning procedures are critical in order to maintain safety and quality of products. Cleaning, in general, addresses the overall hygiene but it turns critical when the hygiene levels are defined, parameters set, procedures defined and finally tested for validation certification.

“Critical cleaning is an indispensable practice in crucial manufacturing premises like pharmaceutical drugs and formulations to ensure best in class product quality,” says Prashant Nagre, CEO, Fermenta Biotech Limited. “In pharmaceutical processing units, several factors are responsible for contamination at various stages, which can be attributed to air quality, installed equipment, movement of workers and quality of raw material. However, it is the finished product quality that matters most in drug production, as contamination at terminal stage of processing cannot be reversed.”

More of a closed room area, all surfaces of the production and product storage have different cleaning requirements and standards to meet. The manufacturing equipment goes through cleaning before and after every batch of production to protect product purity. The cleaning is critical as the processes are determined on the analysis of the residue on the manufacturing equipment. Hence, the cleaning methodologies are developed to detect and treat the target residue and the other surrounding product surfaces. Apart from the procedures, the cleaning agents are specified to ensure the residue is removed from the surfaces.

Critical-CleaningThe set guidelines specify the post cleaning tests to ensure there is no cross contamination from product residue, and that it does not impact the next product taken up for production. There are several specific and non-specific methods which vary with the industry segment. The advancement in production equipment enables in-line, on-line and at-line checking to observe the cleaning processes.

The process also engages cleaning agents requiring further analysis of the chemical residue. “Some of the typical critical cleaning laboratory setups include class clean rooms, chemical and alcohol based cleaners like IPA and benzalkonium chloride, antibacterial liquid sanitizers to reduce surface microbial load, air lock doors and air flow vent for air-borne microbes,” explains Nagre.

Aqueous cleaning is one method of critical cleaning. Generally, aqueous cleaner formulations use key ingredients such as surface active agents (surfactants) that are excellent wetting agents. These agents allow the cleaning solution to penetrate into crevices while getting under soils to enable removal. This highly dilute solution removes even stubborn substances from hard surfaces, including stainless steel, glass or plastic.

Different types of residues are best cleaned by either an alkaline or acidic cleaner. Alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues. Formulated cleaners with wetting agents, emulsifiers, dispersants, chelating agents and anti-redeposition agents give the most robust residue removal.

Understanding the properties of both the residue and the hard surface are important and can be used beneficially to improve the aqueous cleaning process, according to a white paper released by Alconox, USA. By understanding the structure, functional groups, molecular polarity, solubility and molecular weight of the residue being removed, it is possible to determine if an alkaline or acidic cleaner would work best for a given cleaning method. In most cases, simply by choosing the correct acidic or alkaline pH range for the type of residue being removed, you will be able to select the correct type of cleaner.

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