Validation of isolator containment performance in accordance with ISPE®
Service area
Safety & containment
Lifecycle
ValidationModernization
Isolator Containment Test at a glance
Internationally recognized testing procedure
Verified CPT compliance
Verifies whether the containment performance meets the defined CPT (Containment Performance Target) requirements in accordance with OEB risk levels
ISPE®-compliant and validated
Conducted according to the internationally recognized ISPE® Good Practice Guide
Higher process reliability
Establishes safe processes based on containment level and product toxicity
Risk control
Minimizes occupational exposure and improves workplace safety
Optimized risk assessment
Detailed insights into the containment performance of your systems
Practical recommendations
Concrete recommendations for action to support decision-making after the study
Scientific know-how
Well-founded evaluation based on SKAN’s experience in sterile manufacturing processes
SKAN expert knowledge
Access to in-depth isolator expertise and practice-oriented test setups
Application
Standardized measurement of particle concentration for maximum safety
For manufacturers of highly potent APIs
During the manufacture of highly potent APIs, strict occupational exposure limits (OELs) must be maintained. The SMEPAC service evaluates the containment performance of isolators, i.e., whether your systems meet the required safety standards.
For pharmaceutical production and filling
In production environments with toxic substances, controlling airborne particles is essential. SMEPAC tests assess the containment capability of filling lines, transfer isolators, or compounding isolators.
For quality and compliance teams
SMEPAC studies enable classification of your systems into OEL and OEB categories. This allows risk profiles and protective measures to be derived with precision. It supports aligning safety strategies with product toxicity.
Process
Your path to verified containment: the SMEPAC process
1
Process analysis
Workshop to analyze your processes and define a tailored study strategy.
2
Planning and protocol development
Preparation of an approved test plan and a detailed protocol with all parameters.
3
On-site execution
Simulation of your process using surrogate material, air, and surface sampling at critical points, and analysis by a certified laboratory.
4
Results documentation and evaluation
Creation and release of the full study report, comparison of results with target values, and assessment of containment performance.
5
Results review
Detailed presentation and discussion of results, plus clarification of potential next steps or further studies.
Service highlights
Your investment in safety and compliance
Verified OEB compliance
Controlled exposure, precise risk profiles, and defined protective measures.
Industry standard
Testing in accordance with the ISPE® Good Practice Guide for containment performance of pharmaceutical equipment.
Leveraging SKAN expert knowledge
Years of experience, well-founded test planning, execution, and assessment by the SKAN specialist team.
Definition of study design during a strategy workshop
Study
Customized on-site containment study
Documentation
Comprehensive study report
Airborne particle sampling (air sampling)
Collection of airborne particles at defined measurement points outside the isolator using personal or stationary air sampling during process simulation
Surface sampling (swab samples)
Collection of swab samples from critical surfaces around the isolator to determine possible particle deposits of the surrogate material
Quantitative laboratory analysis
Determination of the surrogate concentration in the samples by a qualified external laboratory using validated analytical methods
Evaluation of measurement results
Comparison of the measured concentrations with defined target or limit values to evaluate the containment performance of the system
FAQs
SMEPAC stands for Standardized Measurement of Equipment Particulate Airborne Concentration. It is a standardized test following the ISPE® Good Practice Guide to assess isolator containment performance against toxic particles.
It protects personnel from excessive exposure to potent substances, enables classification of your systems according to OEL/OEB, and ensures regulatory compliance.
All isolators or closed barrier systems for the processing of potent products, e.g., aseptic-toxic or toxic isolators, filling lines, material transfer or compounding isolators.
The measuring results are compared to defined target values. If this reveals insufficient containment performance, we will discuss possible follow-up tests or measures.
In the late project phase, once the equipment is fully set up and IQ/OQ qualification is complete. At that point, a realistic test is possible.
