In the export trade of water based lubricant, the safety compliance of ingredients is an unavoidable "lifeline." Especially the product's preservative system, which directly determines whether it can pass the extremely stringent toxicology and biocompatibility tests of the US FDA and EU MDR. As consumers demand "additive-free, low-sensitivity" products, designing a preservative solution that ensures a three-year shelf life without causing any invisible harm to delicate mucous membranes has become the technical core for brand OEMs.
Traditional preservative systems often contain parabens or methylisothiazolinone (MIT). Although these ingredients are inexpensive, they are easily identified as allergens in the European and American markets, leading to customs detention or product removal. Modern medical-grade formulations are fully shifting to "green preservation" or "self-preservation" technologies, creating an environment unfavorable to microbial growth by precisely controlling the osmotic pressure and pH of polyols. This technology has a very high threshold, requiring factories to operate in a Class 100,000 cleanroom and undergo 21 quality control procedures to strictly control microbial and heavy metal residues. Only factories with medical device production qualifications can ensure that the preservative system protects product stability while maintaining the balance of the vaginal microenvironment.
When choosing an OEM partner, brands should prioritize factories holding ISO13485 and FDA certifications. A compliant preservation solution not only passes rigorous laboratory tests but also serves as a marketing point for "hypoallergenic and tear-free," directly enhancing end-product premium pricing. In international operations, compliance in preservation systems is not just a technical issue but the fundamental safeguard for brands to avoid return risks and build high-end market credibility. Opting for high-standard R&D collaboration enables brands to achieve twice the results with half the effort in the export arena.
