How to Avoid Contamination in API?

Posted by Akums Drugs & Pharmaceuticals Ltd on November 7th, 2022

 An Overview

Contamination or adulteration is one of the major problems that the pharmaceutical industry faces nowadays. Recognizing the sources of adulteration and maintaining good standards of hygiene and purity can help pharmaceutical manufacturers to be safe and provide quality products.

API Manufacturing

API manufacturing is a crucial process in the whole manufacturing of the pharmaceutical sector. As the name suggests API, Active Pharmaceutical Ingredient refers to the active element of any medicine which affects the disease and works on the symptoms of any ailment. Considering Paracetamol tablet, paracetamol is the major ingredient. If the quality of this API gets affected by contamination then it can keep the safety and security of the patients at harm. In case of contamination, the reputation or goodwill of the pharmaceutical firm can also be put at stake so maintaining the quality, actual formulation away from contamination can be helpful for companies to give away quality-based services, a good name for the manufacturing unit, and offering good services at all stages.

API pharma companiestake extra care and remain vigilant while involved with API manufacturing as they know that adulteration in the pharmaceutical sector can lead to disastrous consequences. It can hamper the safety of patients’ health and can affect business sustainability. Prevention from contamination in manufacturing and production is crucial.

Measures to prevent contamination

Prevention is the first step towards any happening. API pharma companies in India and abroad take good care in the manufacturing of API. They comply with all the statutory norms to ensure public safety at large. Sterile and all forms of testing are to be done authentically to check any contamination or if found can be rectified too. State and federal regulatory agencies have strict expectations and approaches to testing pharmaceutical products for adulteration. Only cleaning is not effective for the same, it is vital to recognize and avoid the occurrence of contaminants that stance a stern risk to a drug product or ability. Though some purification and cleansing measures are considered fruitful, prevention is fundamental in maintaining optimal levels in a disinfected situation.

Other than this needs to diagnose the factors responsible for contamination which need to work on thoroughly.

• People who are involved in API manufacturing and packaging need to be trained to maintain the highest standards of cleanliness and health standards. They should be taught to use personal protective equipment to maintain safety. They should be highly qualified and has professional training in hygiene and cleanliness.
• Infrastructural constraints like poor design, inadequate space, waste management measures, improper ventilation light or air filtration system, and inadequate cleanliness or sanitization practices may hamper the manufacturing process and lead to contamination which needs to be given due attention. Steady cleaning and sanitization are the core of preventing pharmaceutical contamination.
• The quality, authenticity, and control of raw materials can cause further contamination, along with this improper handling or storage, poor labeling, sampling, and testing of raw materials, or usage of poor-quality materials that do not meet the accepted guidelines may lead to contamination.
• During manufacturing also, lack of production facility, non-presence of statutory compliant hygiene and cleanliness standards, lack of proper zone or inadequate spring-cleaning & maintenance status labeling on materials and equipment used in the manufacturing process can lead to contamination which needs to be checked at every level.

 Akums drugs and pharmaceuticals Ltd.

 Akums drugs and pharmaceuticals ltd. is one of the active pharma ingredient manufacturers in India, who are known to be the best quality server and offers the best API manufacturing flawlessly and proficiently. Their quality is sustained throughout the process from start to finish. They assure the best manufacturing practices with their world-class infrastructure facility and best manufacturing facilities.