SOURCE OF SPOILAGE, PHARMACEUTICAL MICROBIOLOGY

1. MICROBIAL SPOILAGE SOURCES OF MICROBIAL CONTAMINANTS MICROBIAL SPOILAGE OF PHARMACEUTICAL PRODUCTS

2. Microbial Spoilage Microbial spoilage is defined as “deterioration of pharmaceutical products by the contaminant microbe. This refers to damage to food, pharmaceutical products that is caused by micro organisms (bacteria, moulds and yeasts). Micro organisms can grow in almost all kinds of food products. As micro-organisms occur everywhere around us, there is always a risk of microbial spoilage.

3. Microbial Spoilage Microbial spoilage includes the contamination of pharmaceutical products with the microbes which leads to spoilage of the products affecting Drug safety and quality, and it not intended for use. Shortly defined as deterioteration of pharmaceutical products by the contaminant microbes.

4. SOURCE OF CONTAMINATION

5. SOURCE OF CONTAMINATION Raw materials (water and materials with natural origin have microbial activity) Pharmaceutical industry environment-wet sites Poor sterilization Lack of aseptic area for manufacturing No proper Cleaning and sterilization of equipments Low grade Packaging e.G. Cardboard, corks, papers are unsuitable packaging materials

6. SOURCE OF CONTAMINATION Containers that are frequently re-used but not cleaned Repackaging of products purchased in bulk into smaller containers During poor Processing and handling of material and equipments without following of SOPs Poor Storage conditions Transportation problems like using of contaminated vehicles and surfaces during transport and handling.

7. SOURCE OF CONTAMINATION

8. Personnel Personnel who are supervising or performing drug manufacturing or control can be a potential source of microbiological contamination and a vector for other contaminants.

9. Reason for contamination from Personnel Lack of training of staff Direct contact between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product Inadequate personnel (staff) cleanliness

10. Reason for contamination from Personnel Access of unauthorized personnel into production, storage, and product control areas Inadequate gowning and personnel protective equipment, Malpractices like eating food, drinking beverages, or using tobacco in the storage and processing areas.

11. Buildings and Facility The buildings & manufacturing facilities may also contribute to the contamination. Inadequate filth Control (मैल, गंदी धूल, गंदगी) Inadequate pest controls Rough floors, walls and ceilings Lack of air filtration systems

12. Buildings and Facility Insufficient size and inadequate organization of the space leading to selection errors like mix-ups or cross contamination between consumables, raw materials, in-process materials, and finished products

13. Buildings and Facility Improper lighting and ventilation Poorly located vents, and drains Inadequate washing, cleaning, toilet, and locker facilities to allow for sanitary operation, cleaning of facilities, equipment, and utensils; and personal cleanliness.

14. Equipments The equipment and utensils used in processing, holding, transferring and packaging are the common source of pharmaceutical contamination.

15. Equipments The main reasons for contamination from equipment include: Inappropriate design, size, material leading to corrosion and accumulation of static material and/or adulteration with lubricants, coolants, dirt, and sanitizing agents Improper cleaning and sanitization

16. Equipments Design preventing proper cleaning and maintenance Improper calibration and irregular service, Deliberate use of defective equipment

17. Materials The raw materials used for production can be a potential source of contamination. Storage and handling mistakes causing mix-ups or selection errors. Contamination with microorganisms or other chemicals. Improper labelling

18. Materials Degradation from exposure to excessive environmental conditions such as heat, cold, sunlight, moisture, etc. Improper sampling and testing. Use of materials that fail to meet acceptance specifications.

19. Manufacturing Process There are various opportunities for contamination of raw material, intermediates or packaging materials throughout the manufacturing process. Lack of dedicated facilities to manufacture single product. Inappropriate cleaning in-between batches to minimize the amount of product changeovers Inappropriate zoning

20. Manufacturing Process Use of an open manufacturing system exposing the product to the immediate room environment Absence of an area line clearance according to approved procedures following each cleaning process and between each batch Lack of cleaning status labelling on all equipment and materials used within the manufacturing facility.

21. HOW TO MINIMIZE RISK? Manufacture products in a campaign, with the appropriately qualified cleaning processes and checks performed in-between batches to minimize the amount of product changeovers Utilize a closed manufacturing system. This is where the product is not exposed to the immediate room environment (and vice versa)

22. HOW TO MINIMIZE RISK? Perform an area line clearance according to approved procedures following each cleaning process and between each batch/campaign Zone the facility Use Cleaning Status labelling on all equipment and materials used within the manufacturing facility

23. HVAC System HVAC stands for Heating, Ventilating, and Air Conditioning A poor HVAC system can be a potential source of microbes growth and a transportation mode for dispersing contaminants throughout the manufacturing facility.