Microbiological Safety Cabinets Awareness for Pharmaceutical & Healthcare Sectors

This BOHS Endorsed MBSC Awareness Course is designed to provide delegates with a solid understanding of both managing and using Microbiological Safety Cabinets (MBSCs), with a particular focus on applications within the pharmaceutical and healthcare industries.

Key learning outcomes include:

Gaining a fundamental understanding of MBSC functionality in pharma and healthcare, including their varied applications, associated health risks, and the consequences of incorrect specification and use.
Learning the essentials of specifying, operating, and maintaining MBSCs, along with an introduction to relevant Hazard Classifications and Containment Levels.
Developing knowledge of testing and validation methods, supported by video demonstrations and practical templates such as work instructions, service reports, training aids, and method statements.
Receiving a concise introduction to IQ/OQ/PQ processes and the critical design requirements from specification through to site acceptance testing (commissioning).

On successful completion of this BOHS-endorsed course, delegates will receive a digital Course Certificate issued by BOHS.

This one-day program is available either as an in-person course at the Leicester Hilton Hotel or, on selected dates, as a live online webinar.

It can also be run as an in-house course (in which case use the Contact Form to make an enquiry).

Payment is not required at checkout. Invoices will be sent approx 5-6 weeks before the course.

There are no pre-qual requirements to attend this course.

MBSC Awareness Day – Programme

Introduction

Terms applied to MBSCs and what they mean
Introduction to Hazard Groups and Containment Levels.
Where they are used and the question of Operator vs Product Protection
Applicable legislation (HSAWA 1974), and associated regulatory literature governing Pharma and Healthcare specifically (COSHH, GMP/GxP, HTMs, ISO standards etc)
Competency i.e., the level of knowledge, skills, experience, and training required to undertake design, testing/validation etc.

Typical Applications in Pharma & Healthcare

Safety Cabinets (Class I, II & III) EN 12469 (Automation, Hybrid, bespoke cabinets) information on discharge arrangements, thimble, by-pass, recirc or ducted?
Siting in accordance with BS 5726.
Multi-branch ductwork systems i.e., where VAV and CAV controlled airflow is applicable, and consideration of the pros & cons surrounding this arrangement.
HEPA filters, DOP, filter replacement etc?
Decontamination Methods (VHP, Formaldehyde, Localised strategies)

Hazard Classification

Chemical Hazard Classification – Occupational Health Categorisation (OHC) definitions and examples of OHC 1, 2, 3, 4 & 5
Biological Hazard Classification – Hazard Group (HG) definitions and examples of HG1, 2, 3 & 4.
Lab Containment Levels (CL1 – CL4) and examples of each with a brief overview of the relevant measures and restrictions in place for each level (HSE/ACDP – Management of containment Labs)
Definitions and requirements under COSHH (e.g. Risk Assessment under Reg 6)

Installation Qualification, Operational Qualification, and Performance Qualification (IQOQPQ) of LEV/Containment devices

User requirement specification (URS), and User requirement brief (URB)
Factory Acceptance Test (FAT)
Installation
Commissioning or Site Acceptance Test (SAT), third party validation, ensuring relevant documentation is obtained and approved

Maintenance & Checking

Maintenance Strategies (PPM frequencies)
Weekly testing checks under COSHH L5
Testing/inspection/validation and applicability to relevant standards & regulation
Repairs, modification & part replacement (GxP & Non-GxP Change control etc)
Understanding of service/validation reports (incl Reg 9 TExT) and discussion of the key information that should be included.