Pharmeuropa publishes a Draft Monograph on "Biological Indicators"

On 15 December 2011, the draft of the revised monograph 5.1.2. "Biological Indicators (BIs)in the Preparation of Sterile Products" (formerly "Biological Indicators of Sterilisation") was published for comment in the Pharmeuropa. The deadline for comment is 31 March 2012.

The content of the draft has been completely revised to meet the current technological developments. Here an overview of the main chapters:

1. Introduction
2. BIs for sterilisation processes
2.1. Description of BIs
2.1.1. Inoculated carriers
2.1.2. Self-contained BIs
2.1.3. Custom-made BIs
2.2. Requirements for BIs
2.2.1. Manufacturer's responsibilities for BIs
2.2.2. User responsibilities for BIs
2.3. BIs for steam sterilisation
2.3.1. Test micro-organisms
2.3.2. z-value
2.3.3. Choice of BI units or spore inoculation
2.4. BIs for dry heat sterilisation
2.4.1. Test micro-organisms
2.4.2. Resistance of BI-units
2.5. BIs for gas sterilisation
3. Microbiological evaluation of membrane filtration
4. Indicators for depyrogenation processes
4.1. Characteristics of the indicator

Here is a summary of the most significant changes and improvements:

1. Introduction

BIs are no longer advised to for defining the suitability of radiation sterilisation cycles..

2. BIs for sterilisation processes

Three types of biological indicator preparations are described: Inoculated carriers, biological indicators in ampoules or tubes (self-contained indicators) and "custom-made BIs". The document carries on with the description of responsibilities regarding the selection and characterisation of manufacturers and users. A central change has been made concerning the definition of "passed/ failed" criteria for sterilisation. The current monograph stipulates that "no revivable spores" should be found while the draft document requires that "the sterilisation process should demonstrate a lethality level that enables a survival rate between 1per 10 and 1per 10.000 BIs."

2.3. BIs for steam sterilisation

The use of Geobacillus stearothermophilus for alternative sterilisation procedures with a F0 value between 8 and 15 is stated as not appropriate. Instead, an alternative test organism should be used. The use of spore suspensions is also presented for the assessment of sterilisation procedures for stoppers.

2.4. BIs for dry heat sterilisation

Because of the high lethality of standard process (2 hours at 160°C), the process assessment should be performed with biological indicators at a 10°C lower temperature.

2.5. BIs for gas sterilisation

Because of the multitude of procedures and the lack of a reference cycle, no criteria for biological indicators have been established. It is the responsibility of the user to determine the appropriate biological indicator and sterilisation cycle.

3. Microbial evaluation of membrane filtration

A test for the microbiological evaluation of the membrane filtration process has been added.

4. Indicators for depyrogenation processes

This procedure has been now clearly separated from the sterilisation procedure and presents a list of characteristics of Lipopolysaccharid preparations which the manufacturer must comply with.

Compiled by:
Dr Andreas Mangel
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

You can comment the draft document. To do this, please visit the

Pharmeuropa page. Open "English" on the left hand side by clicking on the '+'. By clicking on 'Issue 24.1" a pop-up window will open where you can log in for free. The access data will be sent to you per e-mail.

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