In House Testing & Quality Control

With approximately 85% of our current manufacturing as OTC products, our analytical laboratory’s capabilities encompass the entire range of testing and methodology validation required for full-service product development. Your products will undergo numerous tests and quality checks using state-of-the-art equipment in our in-house facilities to ensure safety, stability, and compliance with applicable government regulations.

Powerful Analytical Lab Capabilities

Our analytical laboratory capabilities allow for the identification and quantification of ingredients within our formulas. The advanced and sophisticated analytical laboratory is utilized at all points and processes in our company. This includes the R&D formulation stage, incoming raw material testing, vendor validation, accelerated and 3-year longitudinal stability testing, in-process bulk testing, and finished good testing.

Our instrumentation includes Energy Dispersive X-Ray Fluorescence Spectroscopy (EDX), which is used to rapidly quantify titanium dioxide and zinc oxide in mineral sunscreens. High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are employed together to identify active ingredients in most of our OTC products.

Microbiology Testing, Clinical Testing, and Quality Control

Starting at the development stage, our in-house Preservative Efficacy Testing (PET) ensures product sterility throughout its shelf-life. Our PET test exceeds USP 51 standards by using two inoculations of a combination of ATCC bacteria, house bacteria, yeast, and mold. During manufacturing, all raw materials, bulk, and finished products are tested to ensure no microbiological contamination.

Through our partnership with Bell Clinical Services, we can conduct an array of non-invasive clinical tests to measure skin pH, skin elasticity, TEWL (skin barrier health), skin hydration, sebum level, and more. We conduct in-vitro and in-vivo SPF testing, reducing formulation time and assuring the veracity of the SPF label claim. These clinical tests validate product performance and provide you with support for your product claims.

Quality checks are built into every stage of the manufacturing process, from incoming inspection of components to releasing bulk product for filling along with ensuring filling produces the quality product expected.

PRESERVATIVE EFFICACY TESTING & MICROBIOLOGICAL TESTING

PET measures the effectiveness of antimicrobial preservatives in the formula. All Bell International Laboratories PET testing exceeds USP 51 standards. We fully understand preservative systems and effective microorganism neutralization techniques.

OTC ACCELERATED DRUG STABILITY TESTING

Using FDA guidelines, our OTC products undergo stability testing to provide evidence of the quality of an OTC drug product and the monographed ingredients claimed levels. This helps establish an expiration date for the drug product and recommended storage conditions. Our stability tests are conducted in accordance with current FDA, ICH, and cGMP guidelines.

PRODUCT STABILITY AND PACKAGING COMPATIBILITY TESTING

Concurrently performed alongside OTC Accelerated Drug Stability testing, we review various influences, such as environmental factors, temperature changes, and more, on product quality. Packaging compatibility, storage conditions, and other variables are reviewed to confirm product stability.

CLAIM SUBSTANTIATION

Through our partnership with Bell Clinical Services, we can conduct an array of non-invasive clinical tests, including in-vitro and in-vivo SPF testing, reducing formulation time and assuring the veracity of the SPF label claim.

RAW MATERIALS AND FINISHED PRODUCT TESTING

All incoming raw materials are reviewed to ensure quality and compliance before we accept inventory. Finished products are evaluated for all specifications before release. In the rare situation where a product requires testing unavailable at our in-house labs, we will facilitate testing through a trusted external lab partner.

QUALITY CONTROL INVOLVEMENT

We take quality seriously. Checks are built into every stage of the manufacturing process, from incoming inspection of components to ensuring filling produces the quality product expected.