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In pharmaceutical production, the term “sterile products” is usually used to describe parenteral preparations.
In order for sterile preparations to pass sterility assurance tests, the following things must not be present in the product:
A. Viable Microorganisms: Organisms which are capable of causing diseases must never be found in such preparation.
B. Pyrogenic substances: These are fever-causing products of micro-organisms.
C. Particles: If we can see particles in any of these preparations using the naked eyes, then that product is not fit for administration, and the entire
batch must be destroyed.
#The common things which lead to the possibility of contamination in sterile products?
1. Personnel: The operators have always been the most significant causes of contamination.
2. Poor factory design: Air pressure in aseptic process rooms have to be at a higher differential to all adjacent process room , the floors must be without cracks and easy to clean ,airflow through critical areas must flow in one direction only, temperature and humidity .
3. Unrestricted access to production areas: While only staff who work in the sterile production facility should have access to the production areas.
4. Area Cleaning: Poor cleaning and disinfection of work area are also a major cause of possibility of contamination in sterile products.
5. Water supply: For such a facility, the water used should be distilled water (WFI), and the equipment for regular and copious production of this
grade of water must be available.
#Steps to Eliminate the Possibilities of Contamination in Sterile Product Manufacturing
1. Production staff must be qualified, well trained and re-trained and maintain a high level of personal hygiene. They must always wear protective clothing and never touch the product with their hands during production.
2. Facility design must only be designed to ensure that temperature and humidity can be appropriately controlled, in addition to the installation of UV air-locks and doors should be in place to separate areas with different sterility
requirements. Laminar flow over work areas should have sufficient velocity . Restricted access barrier systems (RABS) should be installed for use by the experts.
3. Access to production area must be limited to well-trained production staff.
4. The finishing of the production area should be such that all windows are easy to clean and do not allow dust to enter. Only stainless steel sinks are permissible. All floors, ceilings and walls must be easy to clean and totally free from cracks. Ventilation and light sources should be designed in suitable manner
5. The staff must maintain a high level of cleanliness
6. Distilled water (WFI) must always be used in production. Also, ensure that water is not allowed to gather and stay in areas where they encourage microbial growth.
