advanced sterile sterile product manufacturing technology .pptx

Presentation on advanced sterile sterile product manufacturing

1. Mahatma   Gandhi   Vidyamandir’s   Pharmacy college Panchavati ,Nashik Pharmaceutical Quality Assurance Department Sub : Pharmaceutical Manufacturing Technology Prepared By Guided by Miss. Punam Uttam Borde Dr. K.V. Bhambar Sir Roll No: 37 Presentation on Advanced sterile product manufacturing technology MGV'S Pharmacy College Panchavati Nashik 1

2. VISION: To be a Centre of professional excellence by contributing honestly to the pharmacist moulding process’ MISSION: Impart high quality education to graduates Contribute to all spheres of professional activities Uphold human values and ethics Nature them into globally competent professional 2 MGV'S Pharmacy College Panchavati Nashik

3. Content Introduction Area planning Environmental Control Utilities and maintenance in the sterile area Walls and floor area Change room Personnel flow Refrences MGV'S Pharmacy College Panchavati Nashik 3

4. Introduction Advanced manufacturing is the use of innovative technology to improve products or processes. It can be defined as "The rate of technology adaptation and the ability to use that technology to remain competitive and add value to the advanced manufacturing sectors“ In advanced aseptic processes, direct contact of the open product with an operator wearing a conventional cleanroom garment is not allowed Gloves or half-suits are used to separate the human operator and the aseptic environment. MGV'S Pharmacy College Panchavati Nashik 4

5. Example: Blow-fill-seal system , prevents direct human contact during the filling/sealing process. Closed-vial filling system , avoids direct contact with the critical zone where the filling needles and post-irradiated closures surface are exposed. Filling of product directly into sealed sterile containers. Restricted access barrier system (RASS) : reduces or eliminates intervention into the critical zone. MGV'S Pharmacy College Panchavati Nashik 5

6. Area Planning: The main objective of area planning is to design manufacturing operations so that the flow of products, people, and raw materials are maintained in a clean environment; likewise, the flow of waste material and products must be separated from the flow of clean personnel and product to prevent contamination. MGV'S Pharmacy College Panchavati Nashik 6

7. Warehousing includes functions such as receiving, shipping, and in-process storing of raw materials and finished products… Receiving and storage of incoming material Receiving areas include unpacking, sampling, and incoming quarantine material. Shipping area contains quarantine material before shipment Storage of finished products and certain raw materials need special environmental storage conditions, such as temperature and humidity control. MGV'S Pharmacy College Panchavati Nashik 7

8. Environmental Control: Sterile products are very critical and sensitive in nature hence it requires a very high degree of precautions and prevention in their preparation and there shall be strict compliance with standards prescribed by regulatory authorities. Zones as per the Gazette of India White zone: final step (filling of parenteral) Gray zone: weighing, dissolution, filtration Black zone: storage MGV'S Pharmacy College Panchavati Nashik 8

9. Environmental Control Zone: MGV'S Pharmacy College Panchavati Nashik 9

10. 1) Zone 7:- filling line:- The walls of the filling area are the last physical barrier to the ingress of contamination, but within the filling area a technique of contamination control known as laminar flow may be considered as the barrier to contamination. 2) Zone 6:- filling area:- Zone 6 is a distinct zone of the controlled environment area for an aseptic filling process but may not be distinct zone for non-aseptic filling process. 3) Zone 5:- weighing, mixing, and transfer area:- Zone 5 encompasses activities of "weighing, mixing, filling or transfer operations" addressed by c GMP section 212.81 which are not handled as zone 6 but which require a controlled environment. MGV'S Pharmacy College Panchavati Nashik 10

11. 4) Zone 4:- clean area:- Activities in this may include washing and preparations of equipment or accumulation and sampling of filled product. 5 ) Zone 3:- general production and administration area :- The third zone of environmental controls is formed by the periphery of the general production area. 6) Zone 2:- plant exterior:- It is a base point from which to work in determining the requirements for the various control barriers. Control zone 1 might include the maintenance of sterile areas around the facility. MGV'S Pharmacy College Panchavati Nashik 11

12. Utilities and maintenance in the sterile area: Sterile areas aseptic processing areas should have.. 1. Smooth and easily cleanable Floors, Walls, and Ceilings. 2. Temperature and humidity controls. 3. Air supply with HEPA filters under positive pressure. 4. Environmental conditions monitoring system. 5. A system for Cleaning and disinfecting to produce aseptic/ sterile conditions. MGV'S Pharmacy College Panchavati Nashik 12

13. Walls And floors area: The walls and floors of the areas where manufacture of drugs is carried out shall be free from cracks and open joints to avoid accumulation of dust. These shall be smooth, washable, covered and shall permit easy and effective cleaning and dis-infection. The interior surfaces shall not shed particles. A periodical record of cleaning and painting of the premises shall be maintained. MGV'S Pharmacy College Panchavati Nashik 13

14. Change room: In pharmaceutical manufacturing, follow of Entry, and exit procedures for staff and visitors are essential to prevent external environmental dust and microorganism to enter the cleaned area. The following procedure also helps to prevent contamination and cross- contamination inside the manufacturing. According to pharmaceuticals WHO guidelines, there must be a well-defined procedure for entry and exit on-premises. Follow the described procedure below before entering into premises and exit from the premises.. MGV'S Pharmacy College Panchavati Nashik 14

15. Change Room MGV'S Pharmacy College Panchavati Nashik 15

16. Personnel flow: The movement of personnel should be planned during the design of individual plant areas. Each production area may have a smooth and efficient personnel flow pattern, a discontinuous or crowded pattern may develop when several individual production area plants are combined. The flow of material and personnel through corridors is inefficient and unsafe paths for moving materials, particularly if heavy forklifts are required. Discontinuous and crowded flow patterns can decrease production efficiency, increase security problems, and increase the problem of maintaining a clean environment. MGV'S Pharmacy College Panchavati Nashik 16

17. Refrences : Whyte, W., & Eaton, T. (2004). cleanroom and associated controlled environment-part7:separative devices (clean air hoods, gloveboxes, isolators and mini environments).  International Conference for Standardization (ICH) ,  9 . International conference for standardization (ICH) (2004), cleanroom and associated controlled environment-part7: separative devices (clean air hoods, gloveboxes, isolators and mini environments), ISO 14644-7. MGV'S Pharmacy College Panchavati Nashik 17