Really Good question. As, the operation is manual it will be difficult to provide the evidence. Hence, I suggest you can perfom some protocol based studies. The study includes,"Containment studies", "Contamination control concept study", "Periodic monitoring for contamination controls strategies". You can make use of these studies which will help to prove the practices and procedures are able to control the contamination under specified environmental conditions.
If HEPA filters are not able to prevent contamination up to 100% level then what is the solution and how we can check air is free from previous products residues.
I understood you concern. The point is, you can make use of contamination control concept. 1. Focus on avoiding dusting in the area 2. Make use of isolators or closed sysem for operations 3. You can make use of combi filters for more protections 4. The common area AHU (e.g. corridoor, washing area etc.) with 100% exhaust 5. Perform Quality Risk Management and identify further possibilities of contamination and put control measures. Hope this clear your doubts. If you have further questions, please feel free to put your comments. Thank you.
To prevent API to API contamination, 1. You can use Isolator for sampling and dispensing purpose. 2. The API container shall be covered with poly bag. Which should be replaced once API container is opened. 3. Try to order the optimum quantity of API required for manufacturing of the batch. So that, the storage can be avoided. Further you can go through the recorded webinar, some more controls are discussed during our discussion. For further clarification, please feel free to put your questions in comment box. Thank you.
If different types of betalactum products are manufactured in the facility to identify the contamination of all the products by a single analytical method is very difficult, even at traces level. Do you have any solution?
Dear Mr. Awadhoot, All betalactams are having cyclic ring structure. Hence will able to detect at UV range. I understood that, there may be wide variety of product range. Hence, In such case to identify the specific contaminant, you can make use of HPLC with PDA detector. So that, you will have a entire spectrum to detect. Further you can make use of investigations tools, moving further on focussed apporach and identify the probable contaminants. Once this identification is over, you can evaluate on the basis of validated analytical procedure. However, with this discussion, I would like to tell you that, you may able to detect the contaminant if it is widely spread. Hope, this clears your question. For further information/clarification, please feel free to put your question.
Great presentation 👍
Thanks. Please Keep learning !!!
Very nicely explained all important points. Thanks
Welcome
Good information sir....
Thanks. Please keep learning !!!
Good job Sir
raghu raghu Thank you so much for your kind appreciation 🙏🏻
How to find oeb oel data for any oncology api
You need to get it from toxicologists
Can I get the PPT of this presentation? what is the process? Thanks, Venugopal
Hi I do not have PPT of this topic as, it is quite old. But yes, if you need, I can share PPT of current webinars.
How we can ensure contamination of potent products batch to batch .finally it is a human driven process and how we can justify by evidence.
Really Good question. As, the operation is manual it will be difficult to provide the evidence.
Hence, I suggest you can perfom some protocol based studies.
The study includes,"Containment studies", "Contamination control concept study", "Periodic monitoring for contamination controls strategies". You can make use of these studies which will help to prove the practices and procedures are able to control the contamination under specified environmental conditions.
U can also used OEL study
If HEPA filters are not able to prevent contamination up to 100% level then what is the solution and how we can check air is free from previous products residues.
I understood you concern. The point is, you can make use of contamination control concept.
1. Focus on avoiding dusting in the area
2. Make use of isolators or closed sysem for operations
3. You can make use of combi filters for more protections
4. The common area AHU (e.g. corridoor, washing area etc.) with 100% exhaust
5. Perform Quality Risk Management and identify further possibilities of contamination and put control measures.
Hope this clear your doubts. If you have further questions, please feel free to put your comments. Thank you.
If we will segregate API and exepients, but API to API contamination how we can prevent.
To prevent API to API contamination,
1. You can use Isolator for sampling and dispensing purpose.
2. The API container shall be covered with poly bag. Which should be replaced once API container is opened.
3. Try to order the optimum quantity of API required for manufacturing of the batch. So that, the storage can be avoided.
Further you can go through the recorded webinar, some more controls are discussed during our discussion. For further clarification, please feel free to put your questions in comment box. Thank you.
If different types of betalactum products are manufactured in the facility to identify the contamination of all the products by a single analytical method is very difficult, even at traces level. Do you have any solution?
Dear Mr. Awadhoot, All betalactams are having cyclic ring structure. Hence will able to detect at UV range. I understood that, there may be wide variety of product range. Hence, In such case to identify the specific contaminant, you can make use of HPLC with PDA detector. So that, you will have a entire spectrum to detect. Further you can make use of investigations tools, moving further on focussed apporach and identify the probable contaminants. Once this identification is over, you can evaluate on the basis of validated analytical procedure. However, with this discussion, I would like to tell you that, you may able to detect the contaminant if it is widely spread. Hope, this clears your question. For further information/clarification, please feel free to put your question.