A preservative system that looks fine on paper can fail in the bottle. Challenge testing, also called preservative efficacy testing, is the practical way to know whether a formula resists microbial growth under realistic use. For private label buyers, the test report is a launch document, not a formality, and understanding how the study is designed helps you ask the right questions.
1. What the Test Actually Measures
A sample is inoculated with a defined mix of bacteria, yeast and mould, then sampled at intervals to count survivors. The standard inoculum is around 10^5 to 10^6 CFU per gram. The test measures the ability of the formula to reduce that inoculum and then hold it down, not whether the product is sterile.
This distinction matters commercially. A product can be perfectly safe when freshly filled and still fail in a bathroom, because the consumer introduces organisms every time they open the jar. The test is designed to simulate that, which is why the recovery phase usually runs to 28 days.
2. Test Methods: ISO 11930, CTFA and USP
ISO 11930 is the reference used in Europe and increasingly in Asia. It sets criteria by product category, with stricter limits for products used around the eyes and for children. The CTFA method is common in the United States, and USP <51> applies to products positioned closer to pharmaceutical standards.
The methods differ in organisms, sampling days and pass criteria. Choose the method that matches your target market before the first sample is sent, because repeating a study costs both time and money. Many factories run ISO 11930 by default, which is a safe baseline for export. If a retailer asks for a specific method, confirm it in writing rather than assuming equivalence.
3. Matching the Test to the Product
One protocol will not serve a whole range. Water activity, pH, surfactant load and packaging all change the risk profile. A low-pH toner with twenty percent alcohol is a very different environment from a pH 6 cream in a wide-mouth jar.
Products in jars and pumps that allow finger or air contact need the full panel. Single-dose formats can sometimes be tested with a reduced panel, but the justification must be documented. For wipes and pads, the substrate itself can adsorb preservative, so the study must use the finished article, not just the liquid. A high-risk water-based system such as a cream cleanser is shown in the deep cleansing cleanser listing.
4. Reading the Results
Results are reported as log reduction at each sampling point. A typical pass requires a rapid drop in bacterial count within 48 hours and no regrowth through day 28. Marginal results should be regarded as a warning, not rounded up. If log reduction sits just above the threshold, a small change in raw material or packaging can push the product below it.
Look at which organism survived. Gram-negative bacteria and moulds are the usual weak points. A formula that passes but shows mould recovery at day 14 needs a chelator or a different preservative combination before it goes to production. Also check whether the report tested the formula at its worst case, meaning the lowest preservative level allowed by the specification.
5. Documentation Buyers Should Hold
Request the full report, not a summary page: organisms, inoculum level, sampling schedule, neutraliser validation and laboratory accreditation. The neutraliser step is where many reports quietly fail, because a neutraliser that does not fully inactivate the preservative will show false kills.
Keep the report linked to a specific formula version and pack. If the fragrance, the thickener or the pack changes, the study may need repeating. Testing capability and quality systems are outlined on the workshop page, the product range shows the formats already in production, and about us covers the company background. For a project-specific discussion, use the contact page.
Frequently asked questions
Can you produce Preservative Efficacy Testing under our own brand?
Preservative Efficacy Testing is handled as a private label project: you bring the brand and the market position, we cover formula, bulk, filling and packing. Existing bases can be adjusted for texture, fragrance and active level, or we develop from a new brief. Tooling and artwork belong to you, and our name does not appear on the pack.
What is the minimum order quantity?
MOQ is set by net fill per unit, not by category:
| Net fill | MOQ |
|---|---|
| < 15 ml/g | 5,000 pcs |
| 15-50 ml/g (50 included) | 3,000 pcs |
| 50-200 ml/g (200 included) | 2,000 pcs |
| > 200 ml/g | 1,000 pcs |
Several SKUs in one project can share a production run to reach the threshold, and a smaller trial order is possible once the formula is approved.
How long do samples and bulk production take?
Samples take 7-10 working days from a confirmed brief, or 10-15 days when a new mould or artwork is involved. Bulk runs 25-35 days after sample approval and packaging arrival. Repeat orders with an unchanged formula usually move faster.
Which certificates and documents come with the shipment?
The plant runs under GMPC and ISO 22716 with a 100,000-class cleanroom. Each shipment can include COA, MSDS, the full INCI list, stability data and microbiological reports. For the EU we support CPSR and PIF paperwork; for other markets we prepare the file set your importer asks for.
Can we change the formula, fragrance or packaging?
Yes. Texture, viscosity, fragrance, colour and active percentage are adjustable within regulatory limits. Packaging can be sourced by you or by us: tubes, airless bottles, jars, sachets and aluminium foil bags, with silkscreen, hot stamping or label application.
What information do you need to quote?
Category and target function, quantity per SKU, packaging direction, destination market and launch date. With that we reply within 24 hours on business days with feasibility, MOQ and a price range. An NDA can be signed before formulas are discussed.
Need this produced? Talk to the factory.
Wangsha Bio has run OEM/ODM production since 2006: 60,000 sqm plant, 17 lines, 100,000-class cleanroom, GMPC and ISO 22716 certified. Send your brief and we reply within 24 hours on business days with feasibility, MOQ and a price range.
Email lucky@moksha-bio.com | Product range | Workshop



