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 Sphere Healthcare has a major investment in microbiological compliance throughout our processes and facilities.
Led by an imminent in-house microbiologist, Sphere’s commitment in this crucial area of quality management includes: - Monitoring of process water systems
- Environmental monitoring programs
- Preservative efficacy testing
- Raw material and finished product testing
In addition, Sphere Healthcare provides clients with microbiological contract consulting services. Please contact customer service for further information about our microbiological services. Stability
Sphere Healthcare offers fee for service stability testing on any complementary health product. Our significant stability capability draws on: - Large state of the art, multi temperature, multi environment stability rooms
- In-house laboratory facilities, technologies & personnel
- Dedicated Stability Manager / Account Manager
Product stability and label claim compliance is integral to post market compliance. In recognition of this, regulatory authorities around the world are increasingly emphasising stringent compliance in this regard. Sphere Healthcare is extremely well positioned to meet this evolving requirement by tailoring a stability program, protocols, storage and testing regime to suit your needs. Our stability facilities can accommodate long term stability, accelerated stability, and moisture permeability studies and then test to agreed protocols, time stations and specifications.
The stability service available includes: - TGA compliant stability protocol design
- Controlled sample storage
- Stability indicating method development
- Method validation
- Stability testing
- Reporting versus protocol
Our stability program can cater for: - Analysis of vitamins and herbs by HPLC.
- Analysis of oils by Gas Chromatography.
- Analysis of minerals by Atomic Absorption Spectrophotometry.
- Herbal fingerprinting by HPTLC with digital photographic imaging.
- Microbiological analysis.
- Method development and Method validation.
- Physical testing, dissolution, viscosity, p-anisadine value, etc
Sphere’s expertise as a diversified complementary health manufacture together with our large investment in R&D & technical talent strongly positions us as a very capable stability partner.
For a quote or further information please contact: Parthiv Mehta, Compliance & Stability Manager direct: +612 9733 4553 or customer service.
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