The core control logic of pharmaceutical GMP production facilities revolves around preventing contamination across the entire chain—including personnel, equipment, materials, methods, and the environment. Among these, the protective gloves worn by operators serve as the primary point of contact between personnel and pharmaceuticals or active pharmaceutical ingredients (APIs), and are also the main channel through which biological impurities and allergens are introduced into the facility. According to industry statistics, 83% of pharmaceutical companies list latex protein control as a core criterion for glove procurement in cleanrooms. Traditional natural latex gloves contain Hev b series allergenic proteins. Long-term use not only increases the risk of occupational allergies among operators but also leads to contamination of pharmaceutical solutions due to shed protein impurities. This can result in failure to meet drug biocompatibility standards, triggering GMP audit corrections and the scrapping of drug batches, causing pharmaceutical companies dual losses in terms of compliance and economics. Addressing these widespread industry challenges, Li Jieqing proudly introduces its synthetic latex gloves. Through optimized synthetic material formulations and standardized production processes, these gloves deliver compliant protective performance characterized by low protein content, powder-free design, and low leaching. Suitable for all GMP cleanroom zones—including those for sterile preparations, biopharmaceuticals, injectables, and cell-based therapeutics—they are the preferred choice for hand protection in pharmaceutical production facilities.
1. Low Allergenicity and Low Leaching: Balancing Personnel Health and Drug Quality
The product is developed and tested in strict accordance with 18 domestic and international standards for pharmaceutical consumables, including GB 24788, YY/T 0616, and ISO 21415. Backed by quantifiable, authoritative data, it provides a solid foundation for pharmaceutical companies’ compliant production. Regarding protein control and occupational protection, national standards explicitly set the upper limit for water-extractable soluble proteins in standard medical latex gloves at 200 μg/g, while the threshold for hypoallergenic latex gloves is 50 μg/g. Relevant EU standards also impose strict limits on six major latex allergenic proteins. Long-term use of traditional latex gloves increases the risk of allergies among production line workers, leading to issues such as hand rashes, skin inflammation, and respiratory discomfort. This results in employee absences, reduced production hours, and increased labor costs for companies.
Li Jieqing synthetic latex gloves are made from fully synthetic materials, eliminating the use of natural rubber as a base material. Tested by a CMA-accredited laboratory using the national standard ELISA immunological method, the detected levels of the six major allergenic proteins are near zero, and the water-extracted soluble protein content is far below the industry control limits. Data from six-month controlled trials conducted by multiple biopharmaceutical companies show that after switching to these synthetic gloves, reported incidents of latex allergies among production floor employees dropped to virtually zero, and frontline staff attendance rates steadily improved, effectively mitigating occupational health risks and production disruptions. At the same time, its extremely low protein leaching characteristics effectively prevent protein impurities from contaminating drug solutions and cell culture media, reducing issues such as excessive pyrogen levels and fluctuations in drug efficacy. This helps companies lower the proportion of non-conforming drug batches and successfully pass GMP impurity risk assessments.
2. Powder-Free High-Purity Process, Suitable for High-Grade Aseptic Production Environments
In terms of cleanliness control, the product employs a proven powder-free process combined with multi-stage ultrapure water purification, precisely meeting the dual control requirements for microorganisms and particulate matter in GMP facilities. All types of release powders are strictly prohibited in high-grade cleanrooms, as powder residues can easily carry microorganisms and impurities, forming insoluble particles that may trigger adverse reactions in intravenous solutions. Traditional latex gloves often rely on starch for release, resulting in high levels of powder residue that render them unsuitable for highly sensitive processes such as aseptic filling.
Li Jieqing synthetic latex gloves utilize a chlorinated surface modification process, eliminating the need for powder to aid donning, with powder residue levels far below national standard limits. The product is manufactured and packaged entirely in a Class 100 cleanroom and undergoes eight rounds of countercurrent rinsing with 18.2 MΩ pharmaceutical-grade ultrapure water to effectively remove residual production additives and microparticle impurities. Third-party testing data shows that the surface particulate matter content exceeds the GMP Class 100 cleanroom admission standards; the gloves do not shed particles easily after repeated friction and do not cause particle burst issues. The finished product is sterilized with ethylene oxide, with microbial and endotoxin levels controlled within industry standards. It is free from pathogenic bacteria and can be widely used in core processes such as aseptic filling, freeze-dried drug production, and cell culture, effectively reducing the likelihood of particle exceedances and abnormal sterility test results in cleanrooms.
3. Chemical Resistance and Low Ion Leaching, Suitable for Complex Production Conditions
Designed for the complex conditions of pharmaceutical production facilities, these synthetic latex gloves combine chemical resistance, low ionic leaching, and superior physical properties, making them suitable for all scenarios—including acid and alkali disinfection, routine drug preparation, and precision operations. The leaching levels of all eight water-soluble ions are maintained at extremely low levels, and the total halogen content complies with the ICH Q3D guidance on elemental impurities in pharmaceuticals. The gloves do not alter the pH of pharmaceutical solutions, thereby reducing the risk of metal ion contamination in drugs.
Field tests have shown that when immersed in medical-grade alcohol or dilute acidic and alkaline disinfectants, the gloves exhibit an extremely low swelling rate and show no issues such as additive migration, cracking, or peeling, demonstrating stability far superior to that of traditional latex gloves. Additionally, the product offers excellent tensile strength and puncture resistance, making it easy to handle precision medical devices and ampoules without causing breakage. The gloves also feature a snug fit at the fingertips.
Post time: Aug-10-2026