medium2 Injectable pharmaceuticals Not more than 100 10% of batch or 4 Injectable medical devices containers, whichever is the Ophthalmic and other greater pharmaceuticals in single-dose containers Ophthalmic medical devices in single-dose containers 101-500 10 containers More than 500 2% of batch or 20 containers, whichever is the lesser Ophthalmic and other Not more than 200 5% of batch or 2 containers, pharmaceuticals and whichever is the greater medical devices not in containers More than 200 10 containers Bulk solid products Not more than 4 Each container 5-50 20% of batch or 4 containers, whichever is the greater More than 50 2% of batch or 10 containers, whichever is the greater Pharmacy bulk packages of Less than 5g 20 containers antibiotics Greater than or equal to 5g 6 containers Solid medical devices Not more than 100 10% of batch or 4 units, whichever is the greater 101-500 10 units More than 500 2% of batch or 20 units, whichever is the lesser NOTES 1. This Table incorporates Table 2.6.1-3 (BP and Ph Eur) and Table 3 (USP). If the contents of one container are sufficient to inoculate the two media, this column gives the number of containers needed for both the media together. TABLE 3: MINIMUM QUANTITY OF PRODUCT TO BE TESTED FROM EACH CONTAINER IN THE SAMPLE1 Type of product Quantity of product in unit Minimum container quantity/proportion to be used for each medium from each container2 Liquids Less than 1 mL The whole contents
medium2 Injectable pharmaceuticals Injectable medical devices Ophthalmic and other pharmaceuticals in single-dose containers Ophthalmic medical devices in single-dose containers Not more than 100 10% of batch or 4 containers, whichever is the greater 101-500 10 containers More than 500 2% of batch or 20 containers, whichever is the lesser Ophthalmic and other pharmaceuticals and medical devices not in containers Not more than 200 5% of batch or 2 containers, whichever is the greater More than 200 10 containers Bulk solid products Not more than 4 Each container 5-50 20% of batch or 4 containers, whichever is the greater More than 50 2% of batch or 10 containers, whichever is the greater Pharmacy bulk packages of antibiotics Less than 5g 20 containers Greater than or equal to 5g 6 containers Solid medical devices Not more than 100 10% of batch or 4 units, whichever is the greater 101-500 10 units More than 500 2% of batch or 20 units, whichever is the lesser NOTES 1. This Table incorporates Table 2.6.1-3 (BP and Ph Eur) and Table 3 (USP). If the contents of one container are sufficient to inoculate the two media, this column gives the number of containers needed for both the media together. TABLE 3: MINIMUM QUANTITY OF PRODUCT TO BE TESTED FROM EACH CONTAINER IN THE SAMPLE1 Type of product Quantity of product in unit container Minimum quantity/proportion to be used for each medium from each container2 Liquids Less than 1 mL The whole contents