A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.
The customer required a containment level of 1 µg/m3, to meet this requirement, Freund-Vector designed a coater without the need for a glovebox isolator. Containment was engineered into the equipment itself rather than using an external isolator to meet the requirement.
The test protocol was completed by following the general sampling guidelines contained in the ISPE SMEPAC Guideline (Standardized Measurement of Equipment Particulate Airborne Concentration) and ISPE Good Practice Guide: Accessing Particulate Containment.
The conditions within the test enclosure were consistent throughout the one-day study and were designed to simulate actual work processes and environmental conditions once the equipment is placed into active production.
The system was designed with several features that maintained containment through processing of the tablets and then through cleaning of the entire coater. Key features included:
- Air seal design at all doors
- Isolation values at the charge and discharge ports
- Vacuum Sampling
- Compu control system to manage automatic processing and cleaning sequences
- A Wash-In-Place (WIP) system that contained 17 wash zones for a complete and contained cleaning.
The study consisted of collecting air samples during the Coating process (3 runs) and the Unloading process (3 runs). The air samples were collected with MSA Escort Elf™ battery operated pumps calibrated to a known flow rate of approximately 2.4 liters per minute (LPM). All air sampling pumps used for the study were calibrated before and after each use with a Bios Defender Model 510 air flow calibrator per customary industrial hygiene practice. The Bios Defender air flow calibrator is considered a primary air flow standard which is traceable to a National Institute of Standards and Technology (NIST) standard.
|COATING RESULTS||UNLOADING RESULTS|
|Location #||Description||Average/3 Runs||Location #||Description||Average/3 Runs|
|Location 1||Loading Valve||0.1072||Location 1||Loading Valve||N/A|
|Location 2||Coater Door||0.1691||Location 2||Coater Door||0.0402|
|Location 3||Discharge Valve||N/A||Location 3||Discharge Valve||0.0722|
|Location 4||Left of Coater||0.1112||Location 4||Left of Coater||0.0313|
|Location 5||Right of Coater||0.1915||Location 5||Right of Coater||0.0322|
|Location 6||By Exit Door||0.0358||Location 6||By Exit Door||0.0322|
The final surrogate testing verified that the equipment exceeded the 1 µg/m3 requirement by a large margin as referenced in the chart.