Good explanation many thanks good theoretical information i have just few comments if you allow me: Leak test should be done by vacuum chamber or methylene blue method ( as normal leak test ( invert bottles) will not be suitable for viscous solution and pharmaceutical companies dont rely on it. - water vapour test in pharma company is done under other conditiobd as this test is critical in stability test and temerature and humidity may be 40C/45% or 40/75% depend on permeability of bottle. There are also some other tests as hydrolysis test of glass bottles under temperature to ensure no increase of PH. Leachable and extraxtable test is important test now in all regulation guidelines Thanks Dr.Sherif Amin
جزاك الله خير ولكن عندي استفسار عن الكميات لم تذكر الكميات اثناء الفحص مثلا عند فحص البولي اثلين كم الكميه بالبيكر وكم كمية الماء وماهي الضروف من درجة الحراره يعني الارقام لم تذكر ياريت لو سمحت تذكر لنا كل شىء بالتفصيل والله يحفظك
Good explanation many thanks good theoretical information i have just few comments if you allow me:
Leak test should be done by vacuum chamber or methylene blue method ( as normal leak test ( invert bottles) will not be suitable for viscous solution and pharmaceutical companies dont rely on it.
- water vapour test in pharma company is done under other conditiobd as this test is critical in stability test and temerature and humidity may be 40C/45% or 40/75% depend on permeability of bottle.
There are also some other tests as hydrolysis test of glass bottles under temperature to ensure no increase of PH.
Leachable and extraxtable test is important test now in all regulation guidelines
Thanks
Dr.Sherif Amin
جزاك الله خير ولكن عندي استفسار عن الكميات لم تذكر الكميات اثناء الفحص مثلا عند فحص البولي اثلين كم الكميه بالبيكر وكم كمية الماء وماهي الضروف من درجة الحراره يعني الارقام لم تذكر ياريت لو سمحت تذكر لنا كل شىء بالتفصيل والله يحفظك
دكتور عمرو هو اختبار التسريب دة لة مرجع
موجود طبعا في ال USP و ال JP ،، بس بتفاصيل أكتر من كدة شوية،، ده مجرد شرح مبسط للموضوع