SKAN BI

Biological indicators for validated decontamination processes

Compatibility: Universal
Customization level: Standardized

SKAN BI at a glance

Biological Indicators in SKAN quality

Reliable performance

Minimizes false positives through proprietary inoculation methods
Proven quality

Homogeneous quality in every batch through validated production and a sophisticated quality management system (ISO 9001)
Documentation

ALCOA++-compliant documentation
Optimized for H₂O₂

Specifically developed for demanding H₂O₂ decontamination processes
Smart packaging design

No risk of contact with the inoculated area when removing the carrier
Optimized carrier design

Carrier geometry allows easy transfer into growth media
Easy handling

Simple positioning using adhesive tape or hooks
Expert support

Professional support provided by microbiological experts

Application

Versatile applications in critical decontamination processes

For isolator technology

Qualification and validation of H₂O₂ decontamination processes in isolators. An integral part of the development and establishment of stable, validatable processes, as well as their performance qualification.
For room decontamination

Qualification and verification of H₂O₂ cleanroom decontamination. As biological process indicators, they provide proof of actual microbial inactivation – information that cannot be obtained from physical measurements alone.

Process

BIs as the core of validation and performance qualification

1

Placement of BIs

Strategic positioning in the isolator or cleanroom at representative surfaces. Fixation with adhesive tape or hooks possible.
2

Decontamination process

Execution of the H₂O₂ decontamination cycle with the objective of achieving and verifying a defined microbial reduction. SKAN BIs are specifically optimized for the kinetics of H₂O₂ vapor and fogging processes.
3

Analysis and evaluation

Post-cycle the BI are retrieved and microbiologically evaluated using a growth test. These results are critical: absence of growth confirms that the required microbial kill has been achieved, while growth indicates that the intended reduction was not achieved.

Product highlights

Swiss in-house production for highest quality

Reproducible quality and performance

Homogeneous spore distribution, minimized risk of false positives through proprietary inoculation methods, and separate production and quality control processes. Each batch is tested for spore count and recovery, purity, microbiological identity, and D-value.
Optimized design for easy handling

Primary packaging with controlled opening, safe removal of the carrier, rounded edges for smooth transfer into growth media.
Tailored population options

Variants with 10⁶ or 10⁴ spores per carrier for different process requirements, from high-security isolator processes to room decontamination.

Regulatory requirements

Regulatory assurance for validated decontamination processes

Integration into the CCS

SKAN BIs are an integral part of the Contamination Control Strategy (CCS) in accordance with EU-GMP Annex 1. They provide direct microbiological evidence of process efficacy and support a risk-based assessment within the framework of Quality Risk Management (QRM).
Standards-compliant quality and application

SKAN BIs meet the relevant requirements of international standards such as the SO 11138 series, as well as the pharmacopeial requirements (United States Pharmacopeia USP <55>, <1229>, <1208>, European Pharmacopeia Ph. Eur. 5.1.2). Manufacturing is carried out under a validated quality management system.
Robust data for validation and performance qualification

Verified performance parameters such as D-value, recovery, and purity deliver reproducible results for validation and (re-)qualification. These data support transparent, audit-ready documentation throughout the entire process lifecycle.

Technical specifications

Primary packaging dimensions

66 × 25 mm
BI carrier dimensions

40 × 9 × 0.1 mm
Primary packaging material

Tyvek®
BI carrier material

Stainless steel
Packaging unit

25 SKAN BI per package

Organism

Geobacillus stearothermophilus DSM5934 (corresponds to ATCC 7953)
Populations

>1 × 10⁶ or >1 × 10⁴ spores/carrier

Storage

2–8 °C, dark, in original packaging, without desiccant
Shelf life

8 months for SKAN BI 10⁶, 10 months for SKAN BI 10⁴

FAQs

Spores of Geobacillus stearothermophilus, a heat- and H₂O₂- resistant spore-forming bacterial strain, internationally recognized as the reference organism for steam and H₂O₂ decontamination.
This organism forms highly resistant spores that are particularly difficult to inactivate with H₂O₂ vapor. It represents a “worst-case scenario”. If the process can reliably eliminate these spores, it is considered effective against less resistant microorganisms.
Chemical indicators show physical or chemical parameters (e.g. achievement of H₂O₂ concentration) but do not prove that microorganisms have been inactivated. Biological indicators contain resistant spores and provide direct evidence of microbial efficacy.
- 10⁶: Standard for isolators and high-criticality processes (highest validation requirement).
- 10⁴: For room decontamination and studies where faster inactivation (“kill”) needs to be demonstrated.
The D-value (decimal reduction time) specifies how long it takes under defined conditions to reduce the spore population by 90%. It is central to the reliability of BIs.
This depends on the specific application. In general, BIs are used extensively during the development of decontamination cycles and their initial qualification. In routine operation, they are typically applied periodically or after specific events, such as maintenance, system modifications, or during regulatory requalification.
Tyvek® primary packaging allows controlled air and H₂O₂ penetration, while protecting the carrier and reducing handling-related contamination risks and errors. Unlike glass ampules, the carriers are ready-to-use and can be easily retrieved after decontamination.
A positive result indicates insufficient process performance. Possible causes include incorrect placement, inadequate H₂O₂ distribution, overloading, or unexpected spore resistance. A root cause analysis is required, and the process may need to be repeated.