Validation of Contamination Control in Rapid Transfer Port Chambers for Pharmaceutical Manufacturing Processes.

Shih-Cheng Hu,Han-Yang Liu,Rong-Ben Chiu,Angus Shiue

doi:10.3390/ijerph13111129

Abstract

There is worldwide concern with regard to the adverse effects of drug usage. However, contaminants can gain entry into a drug manufacturing process stream from several sources such as personnel, poor facility design, incoming ventilation air, machinery and other equipment for production, etc. In this validation study, we aimed to determine the impact and evaluate the contamination control in the preparation areas of the rapid transfer port (RTP) chamber during the pharmaceutical manufacturing processes. The RTP chamber is normally tested for airflow velocity, particle counts, pressure decay of leakage, and sterility. The air flow balance of the RTP chamber is affected by the airflow quantity and the height above the platform. It is relatively easy to evaluate the RTP chamber′s leakage by the pressure decay, where the system is charged with the air, closed, and the decay of pressure is measured by the time period. We conducted the determination of a vaporized H2O2 of a sufficient concentration to complete decontamination. The performance of the RTP chamber will improve safety and can be completely tested at an ISO Class 5 environment.

Highlights

The pharmaceutical material transport into the Grade A (equivalent to ISO 5 (ISO 14644-1) [1])filling environments is one of the most common for the causes of the aseptic processing deterioration [2].The design arrangements of the conventional filling facility have placed it in a Grade B environment.Process operations are required while sterile materials are delivered from a Grade B environment to the Grade A filling area
This study presented four tests to evaluate cross-contamination control in the rapid transfer port (RTP) chambers: (1) a quantitative check of the airflow velocities; (2) a particle count test under normal and enhanced airflow velocities; (3) a pressure decay test of the complete containment system at different initial pressures; (4) vaporized hydrogen peroxide decontamination
The aerodynamics allows for a one-way flow or airflow turbulence within the RTP chamber, under negative pressure compared to the surrounding environment

Summary

Introduction

The pharmaceutical material transport into the Grade A (equivalent to ISO 5 (ISO 14644-1) [1])filling environments is one of the most common for the causes of the aseptic processing deterioration [2].The design arrangements of the conventional filling facility have placed it in a Grade B environment.Process operations are required while sterile materials are delivered from a Grade B environment to the Grade A filling area. The pharmaceutical material transport into the Grade A (equivalent to ISO 5 (ISO 14644-1) [1]). Filling environments is one of the most common for the causes of the aseptic processing deterioration [2]. The design arrangements of the conventional filling facility have placed it in a Grade B environment. Process operations are required while sterile materials are delivered from a Grade B environment to the Grade A filling area. Contamination is a key factor in risk analysis of classical aseptic processing areas. The isolator is properly validated and operated which can decrease risk from an environmental contamination to a level approaching zero, the transfer of materials in and out of an isolator is the most probable reason for the loss of the separated enclosures environmental integrity

Objectives

Methods

Results

Conclusion