TSI BioTrak BFPC Implementation Roadmap Instruction Manual

Backed by years of experience, TSI is equipped to support you every step of the way.

Implementation Stages Overview

Prior to purchase, users must be certain that the BioTrak™ BFPC aligns with their intended use and requirements. This preparation often includes training on its operation, reviewing prior studies, and conducting limited testing. Typically, a User Requirements Specification (URS) is created.

Additionally, many users may need to calculate the return on investment (ROI) to support and include in final business case. The project officially begins with the purchase of the BioTrak™ BFPC, at which point engagement with the fill line manufacturer and relevant authorities should also commence.

System design consists of two key components:

• Mechanical Design: Focuses on determining the optimal placement of the BioTrak™ BFPCs. Key considerations include minimizing particle loss in the sample tubing and ensuring easy access to the gelatin filter.
• Digital Integration: Addresses how the BioTrak™ BFPC works with the filling system and manages data handling.

For filling lines where the BioTrak™ BFPC is offered as a standard feature, the required design work may be significantly reduced.

Following installation, the BioTrak™ BFPC needs to be qualified as part of the system and validated as per EP 5.1.6, USP <1223>, and PDA TR33. Per these guidelines, TSI® has performed an extensive primary validation of the BioTrak™ BFPC. This validation involved testing with controlled bioaerosols, which users are not expected to repeat. Instead, users are required to perform a secondary validation to demonstrate that the BioTrak™ BFPC meets their specific intended use. This secondary validation includes non-inferiority and interferent testing.

Once accepted for use, the BioTrak BFPC can perform all in-process environmental monitoring in Grade A environments. Its operation is fully automated, functioning similar to a remote particle counter, with the exception of gelatin filter handling.

The BioTrak BFPC features a well-established calibration process backed by years of proven reliability. However, in the event of an out-of-tolerance (OOT) condition, assessing the impact can be challenging due to the use of multiple sensors for viability determination. To address this, TSI simplifies the process by reporting the bioefficiency, making it easier to understand the impact.

Benefits

The BioTrak™ BFPC is an alternative microbiological method that offers clear benefits for assuring product quality and improving efficiency. While implementing such an alternative method can often be challenging, improved regulatory guidance and the established use of the BioTrak™ BFPC for monitoring Grade A environments have made the process more straightforward. Built on years of experience, this document provides a clear, step-by-step roadmap—from project initiation and system design to validation and routine use following installation.

Support Resources

The supporting resources listed for each stage of implementation include reference articles, validation documents, and testing services. Many of these documents are readily available on the TSI website and can be quickly accessed using the QR code below. To take advantage of additional services and resources, please contact a TSI sales professional.