Containment Performance

ISPE SMEPAC

APPLICATION

  • Evaluate containment performance without potential exposures to potent APIs
  • Evaluate equipment/devices before purchase
  • Obtain baseline data to compare equipment models from different suppliers
  • Obtain baseline data to compare different technologies
  • Evaluate performance of new equipment before production

Step 1. SAMPLING STRATEGY AND PROTOCOL WRITING

We will develop an efficient sampling strategy (i.e. type of sampling, where to sample, number of samples, duration of each sample).

Step 2. REPRODUCTION OF ALL PROCESS STEPS

Our operators will reproduce all process steps, unit operations, and tasks.

Step 3. ON SITE SAMPLING

We will perfrom a comprehensive monitoring of air borne and surface samples, accordingly to the sampling strategy developed.

Step 4. SAMPLE ANALYSIS AND VALIDATION

We will perform on the collected samples all required analysis providing a final report with raw data and results interpretation.

METHODS AND SURROGATES

Our method uses a grouping of different samples placed within the air space surrounding the containment enclosure, plus samples located at potential breach points, the worker, the test enclosure, and the air inside and outside the test environment.

We developed highly sensitive and specific analytic methods to monitor the following surrogates: Lactose, Naproxen and Mannitol.

All our methods are validated according to ICH Q2 (R1).

LACTOSE

  • HPLC-ED
  • CPT/OEL* > 100 ng/m3
  • LC-ESI-MS
  • CPT/OEL* > 10 ng/m3

NAPROXEN

  • HPLC-UV
  • CPT /OEL* > 1O ng/m3
  • HPLC-FLUORESCENCE
  • CPT /OEL * > 1 ng/m3

MANNITOL

  • LC-ESI-MS
  • CPT /OEL* > 1O ng/m3

* The applicability limit depends on sampling method strategy, the value reported represents the best achievable performance.