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Sterility Testing

Sterility Testing

The sterility of a product is defined by the absence of viable and actively multiplying micro-organisms when tested in specified culture media.

Sterility testing should be conducted within a class A Laminar Air Flow cabinet located within a class B clean room, or in an isolator that need not be located within a controlled environment.

ICH QB4 states that the following sterility testing can be used as interchangeable - Ph. Eur. 2.6.1. Sterility, JP 4.06 Sterility Test, and USP <71> Sterility Tests.

Membrane filtration of the product is the preferred sterility test methodology. If the product cannot be filtered, then direct inoculation, immersion, in-situ incubation or combination methods as appropriate are acceptable. In most cases validation of sterility assay is required and would normally be performed once as part of the method transfer process

To determine how many samples and what volume of sample will be required for sterility testing the pharmacopoeias propose the numbers in Table 1 and table 2 below. To complete a validation the amount of sample required for testing needs to be multiplied by x3.

TABLE 1

Minimum Quantity to be used for each Medium Quantity Per Container

Minimum Quantity to be used (unless otherwise justified/authorised)

LIQUIDS

less than 1 ml

1 – 40 ml

>40 ml and #100 ml

>100 ml

 

Whole contents of each container

Half contents of each container but not less than 1 ml

20 ml

10% of contents of container but not less than 20 ml

ANTIBIOTIC LIQUIDS

1 ml

Other preparations soluble in water or isopropyl myristate

Whole contents of each container to provide not less than 200 mg

Insoluble preparations (creams & ointments)

Whole contents of each container to provide not less than 200 mg

SOLIDS

<50 mg

>50 mg and <300 mg

300 mg – 5 g

>5 g

 

Whole contents of each container

Half contents of each container but not less than 50 mg

150 mg

500 mg

Catgut & other surgical sutures for veterinary use

3 sections of a strand (each 30 cm long)

Surgical dressing/cotton/gauze

100 mg per package

Sutures and individually packed single-use material

Whole device

Other medical devices

Whole device, cut into pieces or disassembled

 

TABLE 2

Minimum Number of Articles to be tested in relation to Batch Size Number of Items in Batch

Minimum Number of Items to be tested for each Medium (unless otherwise justified/authorised)

PARENTERAL PREPARATIONS

#100 containers

>100 and #500 containers

>500 containers

Large volume parenterals

 

10% or 4 containers, whichever is greater

10 containers

2% or 20 containers, whichever is less

2% or 10 containers, whichever is less

OPHTHALMIC & OTHER NON-INJECTABLE PREPARATIONS

#200 containers

>200 containers

     If product presented in single-dose containers

 

5% or 2 containers, whichever is greater

10 containers

Apply scheme for parenteral preparations

BULK SOLIDS

Up to 4 containers

>4 and #50 containers

>50 containers

 

Each container

20% or 4 containers, whichever is greater

2% or 10 containers, whichever is greater

ANTIBIOTIC SOLIDS

Pharmacy bulk packages (<5 g)

Pharmacy bulk packages ($5 g)

Bulks and blends

 

20 containers

6 containers

See bulk solids

DEVICES

Catgut & other surgical sutures for veterinary use

#100 articles

>100 and #500 articles

>500 articles

 

2% or 5 packages whichever is greater (max. of 20 packages)

10% or 4 articles, whichever is greater

10 articles

2% or 20 articles, whichever is less


Samples from aseptic fills should be selected from at least the beginning, middle and end of the batch fill. Additionally, SOPs should define criteria for inclusion and collection of samples immediately after interruptions and operator interventions during the filling process. Samples from terminal sterilisation cycles should be selected from at least the potentially coolest part of the load if such a location was identified during validation studies, and from every load sterilised. If an original test is declared invalid, then any samples used for the repeat sterility test should reflect the original samples in terms of sampling locations or aseptic processing times.

 

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