Production Standards And Environmental Monitoring Methods For Medicinal Aluminium Tubes
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In our life, we need many times to take medicines that are packed in the form of liquid, tablets or cream base. But we may not have ever imagined about the packing material that is used to keep the medicine reach to us without any damage to its quality. The production company related to packing material for pharmaceutical purpose have to follow many rules and guidelines given by the food & drug department. Here we are going to discuss one of the pharmaceutical packaging materials that are Aluminum Tubes and the standards & monitoring system that should be followed by production companies.
Medicinal Aluminum Tube:
Aluminum tubes are considered as non-toxic, hygienic material which can protect the drug without manipulating its composition and keep it fresh. Medicinal aluminum tubes are made of high-quality aluminum that protects the drug components from outside elements like UV rays, humidity, dust, micro-organisms and other environmental gases that can contaminate its quality. Aluminum tubes are light in weight, tamper proof and do not have any adverse effect on nature as they are recyclable. It is a reliable packaging material for most pharmaceutical companies all over the world.
Production Standards:
The production unit of the company must have a system for cleaning the production area and such equipment to keep it disinfected. The area of production must be designed, operated and qualified as per international standards. The production unit should have some types of equipment to control air pressure, temperature, dust & humidity. The manufacturing staff should have protective apparel like a face mask, hand glows and others as specified by world health organisation. The machinery which is used in production should be inspected, maintained and sanitized at appropriate intervals. The staff of the unit must have qualifications in operating it and should be trained to take protective measures if, any type of emergency occurs. The quality control unit must be there.
Environmental Monitoring:
Environmental monitoring should be conducted on a schedule which can promptly identify any potential risk of contamination before it affects the product and allows the implementation of corrections. The monitoring procedure should be recorded and documented. Quality of air and surfaces of the room must evaluate and well defined in written with a list of locations. The monitoring program should cover all production shifts and include floors, walls and equipment surfaces.
The authority must investigate scientifically and should give decision unbiased. If, they found any environmental excursion that could negatively affect the quality of the product they should take preventive actions. There should have frequent monitoring on identifying critical sites and a detailed report should be generated like time of monitoring, techniques, frequency, alert level, and actions they take.
Environmental Monitoring and Production Standards are must be followed by a company which is directly or indirectly connected to the pharmaceutical industry as it directly affects human beings and other living species of nature too.
