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Quality Assurance

Our Quality Assurance


Raw Materials/ Ingredients

Synerplex products are derived from Traditional Chinese Medicine formulas and made using the highest quality, non-irradiated herbs. Each herb has been carefully identified, harvested, cut and cleaned before it undergoes the extraction process.

The raw materials are mixed according to the ratios in the traditional formulation and then water-extracted at temperatures 80-90oC (process time: 8-10 hrs). Following the extraction, concentration phase is carried out at 55-60oC with negative pressure. This phase is performed to reduce the water content before proceeding to the spray drying method. The concentrated extracts are then spray-dried in a closed chamber. The dried powders are mixed with volatile oils retrieved from the concentration phase before being granulated to ensure complete collections of active ingredients.

Our extraction procedures are similar to the traditional decoction method since the ingredients are all water-extracted, and there is no concern about solvent residues. In addition, the raw materials/ ingredients are all Kosher certified.

Inspection/ Testing

All raw materials are tested for pesticides and heavy metals (lead, cadmium, arsenic, and mercury) - using HPLC and ICP-MS methods respectively - when received. Every batch of raw material is sampled, and the samples are retained one year past the expiration date of the products for quality control.

During the encapsulation process, our QA/QC specialists closely monitor the physical parameters of the capsules, ensuring that all are intact and that the capsule weight falls within the specifications.

The finished capsules undergo disintegration tests to ensure timely release of the ingredients and microbial tests to screen for the presence of yeast, mould, E. coli, Salmonella spp., Staphylococcus aureus and various other microbial contaminants before being released for packaging. Finished products are retained one year past the product expiration date for ongoing quality control.

Production Facility

Naturo Aid, the manufacturer of Synerplex products, is a pharmaceutical-grade facility based in Canada. The entire production area is fitted with a high performance air conditioning system which keeps each room in negative pressure, and a heavy-duty filtration system for dust/ powder control to prevent cross-contamination of different products. The facility meets Health Canada NHPD Good Manufacturing Practice (GMP) standards and every aspect of the production process follows precise standard operating procedures (SOPs).

Stability/ Expiration Date

The expiration dates for Synerplex Innovative TCM products are determined through accelerated tests and/ or real time tests to ensure that the finished products retain their specified physical parameters, and are free of microbial contaminants throughout their shelf-life.

Regulatory Compliance

Every step of Synerplex product development and manufacturing process fully complies with the regulations from Health Canada regarding natural health products. The formulas have all demonstrated safety and efficacy in TCM Pharmacopoeia, as well as other essential TCM prescriptions, and all Synerplex products have been submitted to Health Canada for product license.




 

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