Contamination in Pharma Products

No doubt, in the pharmaceutical sector, developing technologies, advancements in automation, synchronized engineering, compliant manufacturing systems, innovative techniques and focused strategies has boosted companies’ performance, productivity and profits. But, unchecked human intervention and lapses in the material mixing areas and on the production lines continue to be main hurdle for drug manufacturing.

On the other side, the major source of contamination in drug production can be traced to personnel working in cleanrooms.

According to one research study a typical person sheds 1,000,000,000 skin cells per day of a size 33 µm x 44 µm x 4 µm -- equivalent to a rate of 30,000 to 40,000 dead skin cells shed from the surface of the skin every minute. Of these, Whyte indicates that approximately 10% of particles carry microorganisms. There are, on average, four microorganisms per skin cell.

From this, it can be understood that humans are not only a basis of contamination, but also are a cause for transmitting contamination possibly to areas that could pose a product risk. Microorganisms can spread to the hands by sneezing, coughing or rubbing the eyes and then can be transferred to other persons, and should such organisms settle down towards a product or vital area, they may present a major risk.

In fact, in pharma production process, every activity should be performed as per the standard operating procedure (SOP) of the company. Utmost concern and precautions must be taken wherever needed in terms of line clearance, record documents, materials handling, packing lines, cleaning protocols, cleaning materials usage, quality and appropriate clothing, guidelines for hygiene, sanitation and using protective equipment.

In most cases, pharma companies may take stringent safety measures in all aspects, but when it comes to cleaning jobs, after production, they neglect respective protocols for simplifications by using unqualified labor that lack training in effective and efficient cleaning methods. For management, it may seem a cost effective maintenance plan, but this may lead to a number of problems such as unsuccessful inspections or catastrophic contamination.

For instance, if a pharma company hires labor from a contractor for cleaning and maintenance, then it has to ensure that all cleaning materials, disinfecting solutions and equipment meet ISO classification and requirements, and the workers who are responsible for cleaning production and engineering areas should be provided protective clothing, gloves, footwear, eye-wear, masks, head coverings and appropriate training. Everything should be documented, checked periodically for cleaning consistency, and maintained by clear records matching to specific ISO cleanroom principles and internal Quality Assurance (QA) and safety manuals.

When production areas are not carefully controlled in accordance with GMP, then there’s possibility of contamination or cross contamination. It happens all due to recklessness, human errors, procedural shortcuts and major failures to meet closely controlled cleaning and sanitation standards.

Committing mistakes and responding to regulatory audits and inquiries can cause interruption in a company’s operations. On the other hand, unseemly hygiene in cleanrooms and other vital manufacturing areas can have disastrous outcomes. Besides proper facility planning, flawless lab design, well-structured operating procedures, detailed periodic sanitation and environmental monitoring, it is essential to have qualified and trained staff who must know the distinctive purposes of cleanroom functions to realize the need for the prescribed cleaning protocols and the potential results of any contamination.

Imagine the financial loss and reputation of a company when a contaminated batch needs to be quarantined or made useless, thereby leading to product recalls.

Image source: pharmamanufacturing.com