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BactoSense PURE’s primary validation for pharmaceutical water testing

  • Writer: Martinique Jobin
    Martinique Jobin
  • Jul 10
  • 2 min read
BactoSense PURE's primary validation

In pharmaceutical manufacturing, ensuring the microbiological quality of water is critical for product safety and compliance.


While reliable, traditional methods like membrane filtration techniques and plating can be time-consuming and labour-intensive. BactoSense PURE offers a faster, automated alternative for detecting intact cells in pharmaceutical-grade water and is backed by primary validation to meet pharmaceutical standards.


With the 2023 EU GMP Annexe 1 update encouraging the adoption of rapid microbiological methods (RMM), validated technologies like BactoSense PURE are becoming essential for contamination control strategies (CSS). 


Let’s explore the primary validation process, its results, and why this innovation is a game-changer for GMP-regulated industries. 


What is BactoSense PURE?


BactoSense PURE is a 21 CFR Part 11 compliant flow cytometer designed for real-time detection of microbial contamination in pharmaceutical water systems.


Unlike traditional methods, it provides:


  • Faster results - minutes vs. days

  • Higher automation - reducing human error

  • Continuous monitoring capabilities - enabling tighter process control


The primary validation process 


Primary validation ensures that an alternative method, such as BactoSense PURE, can perform at least as well as the compendial method, for instance, membrane filtration. This rigorous evaluation was conducted over two years by a consortium of experts, including:



Validation criteria & standards


The study followed key regulatory guidelines, including:



Key validation results


BactoSense PURE successfully met all pharmacopoeial performance criteria:


Table 1: Validation Parameters & Results


Parameter

Result

Comment

Accuracy

Pass 

Non-inferior to HPC

Precision

Pass

RSD <30%, non-inferior to HPC

Specificity

Pass

All species detected

Limit of Quantification (LOQ)

Pass

Non-inferior to HPC

Limit of Detection (LOD)

Pass

Non-inferior to HPC

Linearity

Pass

Non-inferior to HPC

Range

Pass

Non-inferior to HPC

Robustness

Pass

Unaffected by changes

Ruggedness

Pass 

Unaffected by test variables


Table 2: Microorganisms Tested (Specificity)


Species

Result

Comment

Pseudomonas aeruginosa

Pass

Pharmacopoeial strain

Bacillus subtilis

Pass

Pharmacopoeial strain

Staphylococcus aureus

Pass

Pharmacopeial strain

Stenotrophomonas maltophilia

Pass

USP <1231>

Ralstonia pickettii

Pass

USP <1231>

Burkholderia cepacia

Pass

USP <1231>

Penicillium expansum

Pass

Mold

Sphingomonas paucimobilis

Pass

Kulakov et al. (2002)

Escherichia coli

Pass

Pharmacopoeial strain

Candida albicans

Pass

Pharmacopoeial yeast


Why this matters for Pharma manufacturers


The successful validation of BactoSense PURE means:


  • Regulatory confidence: Meets Ph. Eur. & USP standards, easing adoption.

  • Faster decision-making: Real-time data enhances contamination control.

  • Reduced risk: Automation minimises human error.

  • GMP compliance: Supports EU Annexe 1’s push for rapid methods.



Primary Validation Package


To simplify implementation, bNovate offers a comprehensive validation package, including:


  • Validation Master Plan (VMP)

  • Validation Summary Report (VSR)

  • Statistical Analysis Report

  • Performance Qualification (PQ) Support


This package helps manufacturers streamline validation and strengthen regulatory submissions.


The future of water bioburden testing


The primary validation of BactoSense PURE marks a significant advancement in water bioburden testing. By replacing slower, manual methods with automated, real-time flow cytometry, manufacturers can enhance efficiency, compliance, and product safety.


Book a demo to learn how to enhance your pharmaceutical water testing. 

 
 
 

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