For lubricating jelly that directly contacts sensitive parts of the human body, product safety is the focal point for brands and consumers. Any minor quality defect can pose health risks and damage brand reputation.
Pingchuang Medical, keenly aware of its significant responsibility, regards product quality as the lifeblood of the enterprise. To this end, it has established a stringent quality inspection process with as many as 21 key nodes, meticulously monitoring and strictly controlling every stage that could affect final product safety, from raw material entry to finished product release.
These 21 quality inspection steps, like a fine-meshed quality protection net, ensure every drop of lubricating jelly is pure, safe, and stable:
1.Raw and Auxiliary Material Incoming Inspection: This is the first checkpoint. All raw materials, auxiliary materials, and packaging materials entering production undergo strict qualification audits and multi-item testing, including supplier qualifications, COA (Certificate of Analysis) verification, appearance, odor, key physicochemical indicators (e.g., pH, purity), and microbial limits. Non-compliant materials are strictly prohibited from entering storage.
2.Production Water Monitoring: A medical-grade purified water system is used, and the conductivity, Total Organic Carbon (TOC), and microbial content of the purified water are monitored in real-time online and through regular sampling and testing to ensure production water meets pharmacopeia standards.
3.Production Environment Monitoring: Regular monitoring of the Class 100,000 cleanroom's air cleanliness (suspended particles, settling bacteria, airborne bacteria), equipment surface cleanliness, and operator hand hygiene ensures the production environment continuously meets GMP requirements.
4.Weighing and Ingredient Proportioning Review: A double-check system is employed during raw material weighing and compounding to ensure the accurate addition of each ingredient, preventing formulation deviations due to human error.
5.Semi-Finished Product Key Indicator Testing: After key processes like emulsification and homogenization, semi-finished products are tested for appearance, color, odor, pH, viscosity, and uniformity to ensure compliance with process requirements.
6.Microbial Process Control: Samples are taken at multiple production stages (e.g., after compounding, before filling) for microbial testing to monitor microbial contamination during the process.
7.Filling and Sealing Quality Inspection: Online and random checks are conducted for filling volume, seal integrity, and appearance (e.g., leaks, bottle cleanliness).
8.Packaging Material Compatibility and Cleanliness Check.
9.Label and Instruction Content Verification: Ensures label information is accurate and complies with regulatory requirements.
10. Finished Product Physicochemical Full Inspection: Comprehensive testing of key physicochemical indicators such as pH, viscosity, density, and refractive index for each batch of finished products.
11. Finished Product Microbial Limit Test: Strict testing for total aerobic microbial count, mold and yeast count, and specific pathogenic bacteria (e.g., Staphylococcus aureus, Pseudomonas aeruginosa) according to pharmacopeia methods.
12. Heavy Metal and Harmful Substance Residue Testing (based on product characteristics and regulatory requirements).
13. Irritation and Sensitization Testing (for new formulas or high-risk raw materials).
14. Stability Studies: Accelerated and long-term stability tests on finished products to ensure quality stability within the shelf life.
15. Retention Sample Observation and Traceability.
... (Some detailed checkpoints omitted here to aim for 21, could include packaging material microbial tests, final packaging integrity, transport simulation tests, etc.)
16. Final Release Audit Before Ex-Factory: Products can only be released after all inspection records and reports are reviewed and approved by the QA (Quality Assurance) department.
It is through these 21 interlinked and strictly controlled quality inspection steps that Pingchuang Medical implements the "safety first" philosophy in every detail of production. Pingchuang Medical, with its stringent requirements far exceeding industry standards, ensures every unit of lubricating jelly produced allows consumers to use it with peace of mind and confidence.
