Activities of Containment Technology

Engineering, Manufacture and Validation of Containment Solutions for the Manufacture of Solids in Pharmaceutical Production Rooms

In order to ensure the OEL levels required by the customer during: Manual handling and
Machine production of pharmaceutical solids it is of the utmost important that containment is not broken at any time and at no point.

Containment Technology’s activities include:

Engineering Turn-key solutions and integrated concepts for the manufacture of solids in the pharmaceutical industry

Consulting in the planning of new production rooms and production lines.

Analysis of existing production processes.

Development of best possible turn-key solutions such as:

• Optimisation of the production process
• Effective dust capture at the point of origin
• Air management within units and in production rooms
• Adaptation of the filter unit to process and room conditions

Manufacture of HEPA filter units and HEPA filter cassettes Delivery of units for manual handling and pharmaceutical production machines

• Manufacture of tailored HEPA filter units and HEPA filter cassettes for application in pharmaceutical production processes.
• Delivery of units for the manual handling of pharmaceutical solids, such as:
  – Laminar flow cabins
  – Barrier systems and
  – Isolators.

Validation of integrated solutions in compliance with OEL limits = ( Operator Exposure Limit )

“We are committed to the continual improvement of our performance.”

During system validation, the following validation steps are executed:

Installation Qualification = IQ
Operation Qualification = OQ
Production Qualification = PQ

DEHS particle measurement by laser particle counters
to test the filter efficiency of the installed HEPA filter cassettes in the filter units

OEL measurements after the installation of new systems, in order to:

• Document which improvements can be implemented for existing units.
• To verify that the required values are consistently adhered to for new units.

Air Management in barrier systems and in production rooms

Oil mist measurement of air fl ow here within a barrier unit

DEHS / Laser Particle Measurement of the filter efficiency of the installed HEPA filter cassettes and sealing check

Test aerosol: 600,000 particles. Particle size distribution: 0.1 – 0.3 μm /minute (MPPS – Most Penetrating Particle Size)

OEL / Gravimetric Measurement of the dust load of inhalable air within production rooms:

Verification of the dust load in the range of < 1 μg / m³ to 5,000 μg / m³ (OEL 1 – 5)