Milliflex Quantum 快速检测系统产品说明书

Validation Summary Addendum
Milliflex® Quantum Rapid Detection System
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MilliporeSigma in the
U.S. and Canada.
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This information provided in this document (or in any other literature) is subject to change without prior notice and shall not constitute a commitment on our part or the part of any of our affiliates. We expressly decline all warranties and do not assume any responsibility for any errors that may appear in this document. This manual is believed to be complete and accurate at the time of publication. In no event shall we or our affiliates be liable for any damages, including but not limited to incidental or consequential damages, in connection with, or arising from, the use of this document or associated literature.
Table of contents
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Introduction
This document is an addendum to the Milliflex Oasis® system for bioburden and pharmaceutical water testing validation summary and to the Milliflex® Quantum - universal reagent kit - method validation summary.
Please note that the documents mentioned above are the documents of reference to consider when validating the Milliflex® Quantum rapid detection system in conjunction with the Milliflex Oasis® system.
Milliflex Oasis® system description
The Milliflex Oasis® system is a solution for the microbial testing of aqueous fluids. It is typically used in the pharmaceutical industry and provides an efficient method for monitoring in-process samples, water, aqueous raw materials and finished products for microbial limits testing. It can also be used in the electronics industry to test bacterial levels in rinse water following deionization for microelectronics and for drinking water and beverages including beer, wine, fruit juice, soft drinks as well as their raw materials. The Milliflex Oasis® system for microbiological examination of aqueous fluids is composed of the Milliflex Oasis® pump, the Milliflex Oasis® single-use filtration unit and the Milliflex Oasis® single-use media plate. This system provides a convenient solution for increasing the number of tests per hour while reducing the risk of false results.
Milliflex® Quantum method description
The Milliflex® Quantum rapid detection system allows the rapid detection and enumeration
of microorganisms in filterable samples. The detection is based on universal enzymatic fluorescent staining of viable microorganisms. The staining is non-destructive, allowing downstream specific identification following a positive result.
The procedure requires minimal training, as sample contaminants are trapped by membrane filtration using the Milliflex Oasis® system. After an incubation period that is shorter than with the compendial method, media cassettes are removed and each Milliflex Oasis® membrane
is transferred onto a cellulose pad soaked with 2 mL of staining solution and incubated for
30 minutes at 32.5 °C ±2.5 °C. Fluorescent micro-colonies are counted directly using the Milliflex® Quantum reader (specific LED system) or on a photo displayed on a computer screen by a camera and software. After detection, membranes can be applied again to media for traditional plate count (viability assay), allowing microorganisms to be identified in case of contamination of the sample.
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Purpose of this summary
This summary is designed to provide a basic understanding of the method used to demonstrate full compatibility between the new Milliflex Oasis® system and the Milliflex®Quantum system.
The first part of this guide contains an introduction, a product description, and a comparison of Milliflex® & Milliflex Oasis® materials.
The second part of this guide contains a summary of the test method and the test results used to demonstrate compatibility between the new Milliflex Oasis® system and the Milliflex®Quantum system.
This validation summary shows that the performance of the Milliflex Oasis® system is in accordance with the specified acceptance criteria and offers equivalent performance to the Milliflex® system on all the tested parameters.
4Validation Summary Addendum | Milliflex® Quantum Rapid Detection System
Relevant differences between the Milliflex® and the Milliflex Oasis® systems Changes made to materials and design
The Milliflex Oasis® system is designed, manufactured, and packaged to optimize microbial recovery and minimize cross-contamination, while setting new standards for ease-of-use. To this end, the design has been changed and the materials of several components replaced for improved performance.
Table 1: Summary of changes made to materials and design
Body Styrene acrylonitrile (SAN)Polystyrene (PS)Yes Yes
Cover Polypropylene (PP)Polystyrene (PS)Yes Yes
TSA formulation EP/USP/JP formulation EP/USP/JP formulation No N/A
SDA formulation EP/USP/JP formulation EP/USP/JP formulation No N/A
R2A formulation EP/USP/JP formulation EP/USP/JP formulation, new supplier No N/A
*N/A: Not applicable
The complete list of product characteristics as well as the validation strategy are detailed
in the Milliflex Oasis® system for bioburden and pharmaceutical water testing validation summary.
Important Note: No changes have been made to the Milliflex Quantum®reagent formulation.
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Change to impact assessment and
validation approach
Potential impacts of the changes on performance have been assessed and addressed by a validation plan. All results were found to be within specifications. The tested Milliflex Oasis®system met the acceptance criteria of all tests and equaled or outperformed the Milliflex®system with regards to all the tested parameters.
When switching from the Milliflex® system to the Milliflex Oasis® system, the potential impact resulting from the changes to design and materials is minor:
• Membrane is a key component: the membrane material used for the Milliflex Oasis® system and the filtration area remains unchanged.
• The funnel plastic (SBC) is USP medical grade and the extractables test result is equivalent to that of the Milliflex® system.
• There is no change in the media formulation.
• The plastic used for the Milliflex Oasis® media plate (PS) has been widely used for regular Petri dishes for many decades.
• There is no change to the Milliflex Quantum® reagent formulation.
As a result, the parameters (specificity, robustness, linearity, …) that must be tested
to implement an alternative method to a compendial method remain unaffected by the improvements made. Therefore, based on a risk assessment, a compatibility study was performed to demonstrate full compatibility between the two platforms.
The complete Milliflex® Quantum validation strategy and its results can be consulted in the Milliflex® Quantum - Universal Reagent Kit – method validation summary or during an on-site scheduled audit.
Following the risk assessment two key parameters have been challenged:
1. Milliflex® Quantum fluo recovery
Percent recovery is defined as the percentage of microorganisms that are detected by
the alternative test method compared to the compendial method. In this summary, the percentage of several recoveries is calculated as follows:
Calculation is based on individual values:
% fluo recovery = [(average fluo count) / (average control count)] x 100
2. Milliflex® Quantum viability recovery (re-incubation)
After the fluorescent spots are counted with the Milliflex® Quantum reader, the Milliflex®Quantum membranes are re-incubated on solid media plates, to equal the incubation period of the corresponding control of the standard Milliflex Oasis® method. The colony count observed on the Milliflex® Quantum membrane after re-incubation is called the viability count. Calculation is based on individual values:
% viability recovery = [(average viability count) / (average control count)] x 100
6Validation Summary Addendum | Milliflex® Quantum Rapid Detection System
Validation Tests: Summary
Test objective
The purpose of this test was to verify that the new Milliflex Oasis® system is fully compatible with the Milliflex® Quantum system with regards to the microbial detection performance.
Test sampling
10 units of Milliflex Oasis® filtration units plus media plates and 10 Milliflex® filtration units plus agar cassettes were used per test microorganism.
The test was performed using the following items:
Milliflex Oasis® setup:
Milliflex Oasis® 100 mL funnel - MMHAWG124
Milliflex Oasis® R2A media plates - MMSMCRA48
Milliflex Oasis® Tryptic Soy media plates - MMSMCTS48
Milliflex Oasis® Sabouraud Dextrose media plates - MMSMCSD48
Milliflex® setup
Milliflex® 100 mL funnel - MXHAWG124
Milliflex® R2A media plates - MXSMCRA48
Milliflex® Tryptic Soy media plates - MXSMCTS48
Milliflex® Sabouraud Dextrose media plates - MXSMCSD48
Acceptance criteria
• 70% ≤ fluo R% vs control ≤ 130%
• 70% ≤ viability R% vs control ≤ 130%
Test results
R. pickettii, ATCC 27511***************°C±2.5Pass Pass Pass Pass
S. epidermidis, ATCC 12228***************°C±2.5Pass Pass Pass Pass
All results were found to be within specifications.
Conclusion
The tested items of the Milliflex Oasis® system met the tests’ acceptance criteria and provide equivalent performance levels to the Milliflex® system’s items.
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General conclusion
The results generated using the Milliflex Oasis® system with Milliflex® Quantum and the results generated using the Milliflex® system with Milliflex® Quantum were found to be within the acceptance criteria. Therefore, the compatibility of the Milliflex Oasis® system with the Milliflex® Quantum system has been demonstrated.
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