Product/Service

High Containment - High Potency Materials

Source: Siegfried AG

The increasing trend seen for active pharmaceutical ingredients (API) currently under worldwide development is towards ever higher potency levels and pharmacological activity. Such increased compound potency involves, however, associated potential occupational health hazards that require adoption of a range of special containment measures to ensure safe operation through all phases of development and manufacture.

These measures relate to:

  • protection of personnel 
  • protection of product 
  • protection of the environment

Since 2004, Siegfried has continually invested in its containment technology, controls and the capability for safe handling of such materials. Siegfried offers its customers the capability for early stage development, scale-up and commercial manufacture of high-potency drug substance and drug products, with occupational exposure limits (OEL) ranging down to 1 μg/m3. 

When working together with Siegfried you can expect more from our combination of both drug substance and drug product services, offering you complete integration & continuity of supply for your high potency products. Please contact us for an informed & open discussion regarding your requirements.

For materials below 10 μg/m3 down to 1 μg/m3 (Exposure Category 3 at Siegfried) segregated high containment facilities and production areas are used at Siegfried to control the specific material risks, adopting the following basic principles:

  • Siegfried protects its employees from hazards & risk of harm.
  • Exposure to harmful chemicals must be avoided.
  • Management and employees are well trained to take responsibility for the correct implementation of protective measures. Standard procedures about how to handle HAPI are established and in place. 
  • Technical, engineering and organizational control measures are adopted as the first measure of choice and are augmented with additional measures such as personal protective equipment (PPE) where necessary (risk based approach).

High Containment Facilities and Capabilities

All compatible for materials with OEL down to 1μg/m3:

Drug substance (Zofingen and Evionnaz sites, Switzerand)

  • modern state-of-art development & analytical building (opened 2009) with specific separate controlled areas for synthesis, process & analytical development
  • segregated cGMP production facility for high-potency material process scale-up & API manufacture
  • commercial scale cGMP production facility
  • separate material, waste & personnel workflows

Drug product development (Zofingen, Switzerland site)

  • segregated cGMP high containment development area for formulation development & small-scale sample manufacture
  • separate controlled area for analytical development and quality control
  • available operating equipment & techniques match those at manufacturing scale in Malta facility 
  • separate material, waste & personnel workflows

Drug product manufacture (Malta site)

  • segregated cGMP production areas for high-potency material handling (FDA approved 2011)
  • 4 separate suites for granulation, tableting, coating & blister production
  • range of equipment types (isolators, V-processor, sieving, tablet press, drum coater & blister machine etc) matches that in development
  • separate material, waste & personnel workflows