Sir my question one is
If we have a container of ceftriaxone sodium powder is 10 kg.
And our nedded only 3 kg. From it so after take rm. What is the process of handling of loose container and can we used this loose qty. For next plan.If we can use further so what is sop/guidelines.
And how to maintain sterilty assurance level.
Plz give suggestion
It is advisable to use the entire container of API which is sterile. It may not be possible to maintain the sterility of API (in the original container) once it is opened. Please purchase the sterile API in unit containers as per your standard batch size. Once the API container is opened the entire quantity of API should be used.
However, if rarely required, you can reseal the sterile container (loose) after taking out a portion of API for production. This operation should be carried out in a sterile area using aseptic techniques.
Dear sir my question one is
What is standard batch size
If machine capacity 80000/ shift filling vials
And according to party order qty. is 40000 vials
So what is you advice on standar batch size
You should take a batch size of more than 40,000 vials considering the lower yield of a batch and also you will have to collect the samples for analysis, stability studies, and retention purposes. While deciding the batch size, you must consider the production equipment capacity (mixer, mixing tank, double cone blender capacity, etc).
Plz let me intervene.
Why don’t you procure smaller containers, say 1kg or 2kg or if your operations demand, both. Like what Mr Sudhir Budhkar has said, it is not a good practice to use partial quantity from a sterile container and keep the remainder for the next time usage.
If you are a contract manufacturer and cater to multiple customers, you could take a larger batch for vial filling. Treat that as a mother batch and assign requisite quantities for different customers with appropriate labelling. The trail can be captured in your Batch Packing Record (BPR) with a cross reference of that mother batch’s Manufacturing Record (BMR).
Does that help? Good luck.