Disinfectant Qualification Testing with ReadyNow™
Pre-inoculated Test Carriers for USP <1072> Cleanroom Disinfectant Qualification/Validation Testing
Simplify & Expedite Disinfectant Qualification Testing
Aseptic manufacturing facilities in the pharmaceutical, medical device, and compound pharmacy industries are often required to perform cleaning and disinfectant validations to ensure compliance with Current Good Manufacturing Practices (cGMP) and EU GMP Annex 1.
A cGMP compliant process, requires that the disinfectants used are effective and that efficacy has been demonstrated within the specified controlled environment. This means that you must demonstrate that your disinfectants are effective in your facility, with your methods, by your personnel, on your surfaces, and against your microbes.
Disinfectant validations involve in-vitro efficacy testing that includes the surface challenge test described in USP <1072>. This testing is most commonly outsourced to an external microbiology test lab, and is generally very expensive, time consumer, and can at times be difficult to repeat. We created a solution that lowers the cost, improves repeatability, and drastically lowers the time needed for these studies.
The ReadyNow™ pre-inoculated Surface Challenge Test Carriers are a game-changer for disinfectant qualification studies. These pre-inoculated test carriers are stable and shippable anywhere in the world.
ReadyNow™ Surface Challenge Test Carriers
ReadyNow™ Surface Challenge Test carriers are pre-inoculated with the viable quantity of microbes you need for USP <1072> disinfectant testing. We provide the most commonly tested panel of microorganisms coated on the most commonly tested materials, ready-to-test. Each microorganism offered comes coated on a 2”x2” carrier at a CFU titer of >5.0 logCFU/carrier. This allows for the proper microbial challenge to demonstrate a 3 log reduction of vegetative cells and a 2 log reduction of spores (per USP <1072>). These products are sold in packs of 6 test carriers - three test carriers for positive controls and 3 for testing your disinfectant (6 swabs included with each set of test carriers). Compatible with liquids, vapors, or ultraviolet light.
This product enables a new, more efficient and lower price way of validating your disinfectants. Now you can simply receive the pre-inoculated carriers, apply your disinfectant, swab each carrier to recover the microbes (swabs provided), and enumerate the CFU’s from the swab. For this last step, if you are not setup to do CFU enumeration in-house you can send the swabs to our partner lab.
Neutralizer efficacy and toxicity validation (USP <1227>) will be an important part of your study. We provide the Instant Inoculator™ to make this portion of the test simple as well. Reach out to us for the product Instructions-For-Use (IFU), which will explain the surface challenge carrier test and the neutralizer validation in detail.
If you don’t have the capability to expose the ReadyNow™ carriers to your disinfectant(s) at your site, don’t worry! We’ve got you covered for this. You can opt to have the testing fully outsourced to our partner lab and powered with ReadyNow™ technology.
How It Works
Remove Kit from Storage
Product is stored at 2-8C. Pull out from storage, Ready-to-test.
2. Apply Disinfectant
Apply your disinfectant to the test carriers. Compatible with liquids, vapors, and ultraviolet light.
3. Recover Microbes from Carrier
We provide the swabs (USP 1072 lists swabs as a recovery option). You can enumerate the swabs yourself, or send the swabs to our partner lab for enumeration.
Highlights
Standardized test carriers designed for use with USP <1072> Disinfectant and Antiseptics
Significantly expedite testing and lower cost required for regulatory compliance
Eliminates all prep work for inoculating carriers
Eliminates uncertainty associated with producing inoculated carriers in-spec; each product comes with a Certificate of Analysis detailing mean CFU count for that batch
Compatible with your environmental isolates
Eliminates need to clean and sterilize carriers
Stable for >6 months from manufacture date when stored between 2°C to 8°C
Simplify & Expedite Your Disinfectant Qualification
Contact us today to learn how ReadyNow™ can improve your disinfectant validation protocol.
ReadyNow™ Surface Challenge Test Carrier Product Table
| Carrier Material (2"x2") | Organism | Strain (ATCC®) | Bio-Safety Level | Unit | Cell Quantity | Price |
|---|---|---|---|---|---|---|
| Stainless Steel (304) | Staphylococcus epidermidis | 12228™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Escherichia coli | 25922™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Aspergillus brasiliensis | 16404™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Bacillus spizizenii | 6633™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Candida albicans | 10231™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Pseudomonas aeruginosa | 15442™ | 2 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Staphylococcus aureus | 6538™ | 2 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Stainless Steel (304) | Blank | NA | NA | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Staphylococcus epidermidis | 12228™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Escherichia coli | 25922™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Aspergillus brasiliensis | 16404™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Bacillus spizizenii | 6633™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Candida albicans | 10231™ | 1 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Pseudomonas aeruginosa | 15442™ | 2 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Staphylococcus aureus | 6538™ | 2 | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
| Polycarbonate | Blank | NA | NA | Pack of 6 | >4.0 logCFU/carrier | Request Quote |
Devices are conveniently stored between 2 to 8ºC.
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Request quote for ReadyNow™ Test Carriers for disinfectant validation studies
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