Automated Production and Rigorous Quality Control Automation is used to improve production efficiency and standardization. Advanced hardware and strict work flows were introduced to effectively reduce labor costs while also greatly improving product consistency and quality. Strict quality controls are enforced for each multi-functional medical testing system during the production process from assembly, functional testing, and quality inspection, as well as the production, coating, forming, and packaging of test strips. Thanks to our mastery of the core product technologies, we have developed a production process with high efficiency, flexibility and detection power that ensure the high quality of every product through layers of testing.

Active efforts were made to improve product traceability by enhancing the transparency of medical device information from “material control to home use” for users’ peace of mind. Management of inspections, test results, quality records and batch numbers provide a traceability system that racks every aspect of the production and sales process for medical devices. Full records are therefore maintained for Bioptik’s classic multi-functional testing system products from material purchasing, factory production to shipping. Making the safety of medical devices visible to users boosts confidence in the brand while also fulfilling our corporate social responsibility and accountability.

Quality Control for Raw Materials
To ensure the transparency on sourcing of raw materials, suppliers are required to provide the country of origin, manufacturer, Certificate of Analysis (COA), agro-chemical residue, animal drug residue, and other relevant data on safety and effectiveness. Sourcing of raw materials are therefore closely controlled. Quality control records and reports are compiled for raw materials at the factory. Samples are retained for each batch raw materials and final products in the Sample Room as well.

Clean Room Air Conditioning System
Our Class 100,000 clean room air conditioning systems minimizes the amount of floating particles and pathogens in the air. Effective temperature and humidity control is also in place. Environmental microbiological testing is regularly carried out to ensure the best air quality in the production quality.

Pure Water System
Water quality is purified through Reverse Osmosis (RO) and Ion-exchange Resin filtration systems. Microbial counts in the water are regularly tested to ensure that water used in the factory meet the safety standards for purified water.

Machine Safety and Hygiene
Machinery is checked to make sure they are clean and there is no residue in the pipelines before production. They must also be washed and disinfected with alcohol after production. 304 stainless steel or higher is used for all equipment surfaces that come into contact with the product to prevent rust or mold. Equipment is regularly swabbed and tested.

Thorough screening of raw materials
We provide transparency on the sources of raw materials including country of manufacture, manufacturer, Certificate of Analysis (COA), Material Safety Data Sheet (MSM), Technical Data sheet (TDS), product specifications (SPEC), and efficacy data. Effective control over sourcing of raw materials is enforced during new product development to create cosmetics that are gentle and effective.

Clean Room Management
Over NT$10 million was invested in the construction of advanced Class 100,000 clean room production facilities. A high-grade production environment and standard operating processes ensure high product quality while also greatly reduce the risk of product contamination. The operating environment is regularly monitored for temperature, humidity, microorganisms, and dust. Workers must follow ISO 22716 GMP guidelines for the wearing and changing of clean room caps/face masks/coveralls/overshoes before entering the clean room.

Microbial Management Quality Standard Certification
Product formulas generally undergo five main types of microbial testing: Candida albicans, E.coli, Pseudomonas aeruginosa, Staphylococcus aureus, and Total Viable Bacteria Count; Product acceptance SOP checks for: pH value, stability, challenge test, viscosity, and function. Full standardization of formulas ensure safety and stability.

Automated Filling Equipment
Automated filling equipment (computerized quantitative liquid filling machine) and automated vacuum feed pumps are used at Bioptik. Biomedical-grade quantitative pumps are combined with sanitary-grade conduits and stainless steel hoppers to support the filling of water, oil, lotions and highly-viscous frosting. The raw material does not come into contact with the pump during the filling process to meet the quality requirements for hygiene and safety. The computerized control system controls the quality of each batch with great precision and reduces risk of contamination. Infra-red press-type and 4-wheel servo capper on the back-end reduces the risk of human error and increases product filling output.

Packaging Compatibility Test
The contents and packaging undergo compatibility testing, filling simulation testing, pressure testing, stability testing, thermal-sensitivity testing, packaging durability testing, air tightness testing, and swab testing.

Pre-Shipment Inspection
Products are inspected before shipping to ensure they conform to quality standards and generate the COA. Samples from each batch of final and semi-finished products are also retained for monitoring and traceability management of products in the market.