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FM challenges of pharma manufacturers

In the pharmaceutical industry, cleaning and hygiene hold utmost importance in ensuring the safety of products, consumers and employees. There are four key areas to focus on: production hygiene, personnel hygiene, plant and surface disinfection and performance monitoring, writes Dr Shrenik Shah, Director, Montage Laboratories Pvt Ltd and Chairman, Indian Drug Manufacturers’ Association – Gujarat State Board (IDMA GSB).

Rigorous cleaning and proper hygiene are essential in the pharmaceutical industry to prevent any kind of contamination that can affect the quality of medicinal products. High levels of cleanliness, hygiene and sanitation must be practised through all stages of manufacturing through comprehensive screening: from the personnel working in the manufacturing plant to the production process.

Cleaning as a Good Manufacturing Practice

It has been a basic GMP requirement that all cleaning steps in a pharmaceutical plant be documented accurately, and also validated to prove they work. Once the steps are validated, employees must only follow the approved procedure.

Equipment and utensils shall be cleaned, maintained and sanitised at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.

Some kinds of contamination are often difficult to detect by physical inspection. The claim “It looks clean, therefore it must be clean” is not necessarily true. Laboratory testing for potential contamination is generally not practical, economical, nor reliable.

CGMP guidelines demand improvements to the cleaning programme, taking into account worst-case scenarios, which include:

  • Drugs with higher toxicities
  • Drugs with higher drug potencies
  • Drugs of lower solubility in their cleaning solvents
  • Drugs with characteristics that make them difficult to clean
  • Swabbing locations for areas that are most difficult to clean
  • Maximum holding time before cleaning

The manufacturer can outsource the validation activity with all above requirements to FM companies.

Cross contamination by potent products

The prevention of cross contamination is particularly important when the factory produces products such as steroids, hormones, antibiotics, cytotoxic products and some potentially pathological biological materials. Non-dedicated equipment such as a tablet press (if not adequately cleaned) can contaminate the next product. Such material, even in minute amounts, may have a significant effect on the body, and it is important to isolate them from the environment during manufacturing, and remove their residues from equipment during cleaning.

Mixing tanks, tablet presses, capsule fillers, centrifuges, granulators, filling lines, mixers, conveyors, filters, fluid lines, batch process tanks, tubes and flasks all need to be thoroughly cleaned.

Dr Shrenik Shah


Chemical contamination

This can potentially occur when different products are processed in the same equipment, or when materials such as cleaning agents and lubricants come into contact with products or product surfaces.

It can be avoided by following written cleaning procedures exactly. Changing the steps or conditions may make the cleaning ineffective.

Environmental contamination

Different areas of manufacturing within the facility carry different levels of contamination risk to the product. In areas where the product is exposed to the environment (like in the dispensary, formulation areas and bottle filling rooms), there is a higher risk of contamination. Air control is required (usually filtered), and frequent cleaning of the facility and environmental monitoring are recommended.

Biological contamination

This refers to contamination by bacteria, yeasts, moulds, viruses or any other microorganisms that may be present in the product. This also can include residues from dead microorganisms or endotoxins, which can contaminate injectable products.

The origins of biological contamination are varied, but include the environment, personnel, raw materials, contaminated water, and poorly cleaned or wet equipment.

What needs cleaning?

Mixing tanks, tablet presses, capsule fillers, centrifuges, granulators, filling lines, mixers, conveyors, filters, fluid lines, batch process tanks, tubes and flasks all need to be thoroughly cleaned. The design of the equipment must be taken into consideration. By nature of its construction, some types of equipment will be more difficult to clean than others. Hidden parts and blind holes present unique challenges. Processing equipment used to produce multiple products has a greater chance of cross contamination of ingredients.

Choice of solutions

It’s also important to select a cleaner that is compatible with the surface of the equipment you are cleaning. The cleaner manufacturer should be able to guide you and provide compatibility studies for their products.

Following the cleaning instructions obliges the operators to check whether there is any debris left on the line and whether the line has been disinfected. Finally, to ensure that the work has been done properly, operators are required to visually inspect problem areas on the line.

Monitoring and digitisation

Merely implementing hygiene strategies is not enough; it’s equally important to monitor the effect of the measures taken, analyse the process and improve continuously. With the help of digital tools, an up-to-date view of the entire manufacturing, storage, workwear and cleaning process can be quickly obtained. The incorporation of digitised instructions improves the efficiency of operators.

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