Labconco Cycle Development MBQ

Cycle Microbiological Qualification (MBQ). Includes onsite microbiological qualification per SKAN SOP for H2O2 decontamination cycles with BIs, aeration confirmation, residual detection, and full reporting. Requires isolator in defined conditions.

Supplier:  Labconco LSKIQOQ

Catalog No. 13-756-910

Description

• Comprehensive Cycle Microbiological Qualification (MBQ) - A fully validated microbiological qualification process designed to verify the effectiveness of H₂O₂ decontamination cycles, ensuring compliance with industry standards and regulatory guidelines.
• Onsite Microbiological Qualification - Performed directly at the user's facility to assess the isolator's decontamination performance under real operating conditions.
• Validation per SKAN Standard Operating Procedure (SOP) - Conducted in accordance with SKAN's established protocols to ensure consistency, reliability, and regulatory alignment.
• H₂O₂ Decontamination Cycle Verification - Evaluates the isolator's ability to achieve complete biological decontamination using hydrogen peroxide vapor (HPV) cycles.
• Biological Indicator (BI) Testing - Utilizes validated biological indicators (BIs) strategically placed within the isolator to confirm effective microbial inactivation.
• Aeration Confirmation - Assesses the efficiency of the aeration phase to ensure complete removal of residual hydrogen peroxide, minimizing exposure risks and maintaining a safe working environment.
• Residual Detection and Measurement - Performs precise testing to verify that residual hydrogen peroxide levels meet safety and regulatory thresholds before reintroducing sensitive materials or personnel.
• Full Qualification Reporting - Generates a detailed report documenting all test results, including cycle performance, microbial reduction efficacy, aeration validation, and residual analysis.
• Regulatory Compliance Support - Provides documentation necessary for compliance with GMP (Good Manufacturing Practice), ISO 14644-7, and other industry standards relevant to sterile environments.
• Process Optimization and Troubleshooting -Identifies potential performance deviations and offers recommendations for process improvements to enhance decontamination reliability.
• Essential for Sterile Manufacturing and Research Applications - Ideal for pharmaceutical, biotechnology, and healthcare industries where validated decontamination is critical for product integrity and contamination control.
• Requires Defined Isolator Conditions - The qualification process must be conducted under specified environmental parameters to ensure accurate and reproducible results.

Specifications

• Product Type: IQ/OQ Documentation