Safely transfer and validate proven cycles to new isolators
Service area
Biodecontamination & process validation
Lifecycle
Operation
Cycle transfer and performance test at a glance
Efficiently transfer and validate cycles
No need for new development
With successful cycle transfer, validation of established parameters instead of completely new approach
Rapid implementation
On-site tests reduce downtime
Compliant with regulatory requirements
Solid proof for audits and inspections
Tried-and-tested processes
Standardized methodology with proven tools and BIs
Detailed documentation
Master documents, forms, photo‑based documentation protocols, final report
SKAN expertise on-site
Expert support and guidance with unexpected events
Manufacturer-independent
Can be performed on all isolators with a decontamination system
Flexible adaptation possible
Parameters can be adjusted specifically where necessary
Application
Regulatory-compliant parameter transfer
For pharmaceutical and biotech production
Manufacturers of sterile pharmaceuticals who operate multiple isolators of the same design with identical loading and processes, or who are relocating facilities. Cycle transfer enables safe operation without the need for new cycle development.
For ATMP and cell therapy production
Small-volume, highly sensitive production with frequently changing loads. New loading patterns can be introduced in a targeted and regulatory-compliant manner.
For engineering and qualification teams
Those responsible for commissioning, requalification, or modifications to existing systems. Minimizes time and risks associated with site or layout changes.
Process
Structured workflow for reliable results
1
Requirements analysis
Joint clarification of individual specifications and framework conditions, such as type and positioning of the biological indicators (BI) as well as the planned loading.
2
Creation of test documentation
SKAN creates the test schedules and documents and obtains your approval before the actual tests begin.
3
On-site performance of the tests
Multiple consecutive test cycles are performed directly on the isolator, including monitoring, BI analysis, and logging.
4
Evaluation
Analysis of the results.
5
Final documentation and approval
Creation of a complete documentation package with all protocols, images, and a final report for approval.
Service highlights
Efficiency and safety for your decontamination cycle
Back in production faster
No need for a complete redesign and production downtime is kept to a minimum.
Regulatory compliance
Tests and documentation meet regulatory requirements and provide robust evidence for audits and inspections.
Manufacturer-independent
SKAN services can be performed on isolators from any manufacturer equipped with H₂O₂ decontamination systems.
Transfer of existing, validated cycle parameters to identically constructed isolators
Cycle Performance Test (CPT)
Confirmation of cycle effectiveness following relocation or modification
Options
E.g., definition of loading patterns, worst-case positions, temperature and humidity mapping, CI mapping, enzyme indicator mapping
Study
On-site execution of test cycles on isolator
Data
BI evaluations
Documentation
Master documents, approval, test, and image reports, summary final report
FAQs
If an existing, validated decontamination cycle is to be transferred to a structurally identical isolator or a new loading pattern is to be qualified.
If an isolator has to be requalified after a relocation or room change to confirm the effectiveness of the existing validated cycle parameters.
With a cycle development, parameters are redefined from the ground up. With the cycle transfer/cycle performance test, existing parameters are simply verified.
The duration depends on the scope and the number of test cycles. As a rule, a couple of days on-site are required to perform the test, after which the documentation is created.
No. The tests can be performed on all isolators with H₂O₂ decontamination systems, irrespective of the manufacturer.
