SMEPAC Test to Measure the Tightness of Containment Systems

Working with highly active and hazardous drugs and ingredients requires evidence that the used containment systems are leak proof!

Correctly performing a Standardized Measurement of Equipment Particulate Airborne Concentration (SMEPAC) test for containment exposure measurement is challenging and belongs into hands of experts.

Valicare GmbH, an established GMP service supplier for the regulated pharmaceutical industry since 2002, offers ISPE comliant SMEPAC test services for companies which are using containment systems for processing of particle/dust emitting materials.

A high degree of flexibility and technical process experience is required, because pharmaceutical manufacturers of oral solid dosage (OSD) and active pharmaceutical ingredients (API) use a wide range of containment systems during their R&D and manufacturing processes.

Valicare experts are very familiar with isolators, RABS (Restricted Access Barrier Systems), tablet presses, capsule fillers, mixers and fluid bed systems, because Valicare belongs to Syntegon Technology GmbH, a leading manufacturer of process and filling technology for the pharmaceutical and food industry.

In order to operate such containment systems, the companies need to control and monitor the exposure of their own personnel, facilities and environment.

The purpose of the SMEPAC test is to evaluate particle emissions of pharmaceutical systems and equipment.

A set of measurements is used to assess the capability of the equipment to maintain the concentration of particles during manufacturing processes below a specified limit in adjacent environments.

 

The method includes active (stationary, on persons and additional passive (swab) samling of emitted surrogate material (such as naproxen sodium, lactose monohydrate, mannitol. riboflavin, acetaminophen/paracetamol) during simulated operations within the containment equipment.

Consecutively taken samles are chemically analyzed to determine the surrogate material concentration.

The test results provide documented evidence to which extend the installed equipment prevents the emission of airborne particles during manufacturing processes.

The accopanying risk assessment may result in the necessity to repeat the initial SMEPAC test periodically during the whole lifecyle of the containment system.

Valicare offers the following SMEPAC test services for either containment system users or manufacturers:
 

• Pracitcal workshop to determine the containment performance Target (CPT) based on the occupational exposure limit (OEL), the sampling strategy and surrogate material to be used.
• Preparation of testing plans in accordance with the ISPE methodology.
• On site samplings (static, personal, and optional surface sampling) of airborne surrogate material with the own measuring devices and equipment.
• Determination of concentration in the air by applying validated high-performance liquid chromatography (HPLC) method.
• Final containment report with statistical results according to EN 689 2018 - Workplace exposure.
  Measurement of exposure by inhalation to chemical agents. Strategy for testing compliance with occupational exposure limit values.

Customers receive reproducible results by outsourcing the measurements to skilled experts using standardized methods.
 

For more information about our SMPEAC test services, please visit our website SMEPAC Tests for Containment Systems or contact us.