Bonerge Lifescience

Quality & Safety

Bonerge only supply our customers the highest-quality natural ingredients and formulas, and back them up with documented clinical findings and scientific research.

Every product available through Bonerge was manufactured at our certified state-of-the-art facilities, each has been thoroughly lab tested and manufactured subject to rigid quality control guidelines.

Rigorous
Quality
Standard

Analytical Method Design

Analytical Procedure Life Cycle Management

Analytical Method Development

Analytical Method Validation

Analytical Method Transfer

Analytical Method Verification

Acceptance Criteria

Biologists and chemists at Bonerge set up the acceptance criteria for each item.

Analytical Method Design

Analytical Method Development

Analytical Method Validation

Whole-process Supervision

Every batch of product under Whole-process Supervision

Analytical Method Design

Analytical Method Development

Analytical Method Validation

Well-established Quality system

Bonerge complies with regulatory bodies such as FSSC22000, cGMP, GMP+, HACCP, ISO22000, ISO9001, Kosher, Halal, USDA Organic, Ecocert Organic Standard to meet all our customer requirements. We also evaluate any new certifications our customers need.

Advanced Analytical Instruments

We do test for every batch of our products both in house and in the third laboratories for identity, purity, assay, microbiology, heavy metals, pesticides, and solvent residue when applicable. We employ high-performance analytical tools (such as HPLC, HPLC-MS, GC, GC-MS, PPSL, NMR, ICP, TLC, and FTIR) to ensure total quality.

GC-MS

Headspace gas chromatograph

Atomic absorption spectrophotometer

HPLC-MSMS

GC-MS MS

ICP-MS

Preclinical Studies

Bonerge conducts safety(toxicological) experiments from animals to humans for each new product following international guidelines, our preclinical safety studies including:

Acute Toxicity

Subchronic and Chronic Toxicity

Genetic Toxicity: bacterial mutagenesis, in vitro cytogenetics, in vivo mammalian test.

Clincal Studies

For every new product we introduce to market, clinical trials are the primary and necessary way that our researchers find out if it is safe and effective in people.