📘 SECTION 7: QUALITY CONTROL AND SPECIFICATIONS OF GELLAN GUM
Ensuring Purity, Consistency, and Compliance
Maintaining high-quality standards is essential for both formulators and end-users. At CINOGEL BIOTECH, rigorous testing, documentation, and traceability protocols ensure every batch of gellan gum is safe, consistent, and compliant with international regulations.
✅ 1. PHYSICAL AND CHEMICAL SPECIFICATIONS
| Parameter | Typical Specification | Test Method / Notes |
|---|---|---|
| Appearance | White to off-white powder | Visual inspection |
| Odor | Neutral to slight characteristic | Sensory analysis |
| Moisture Content | ≤ 15% | Oven drying or Karl Fischer |
| pH (0.5% solution) | 5.0 – 7.0 | pH meter |
| Ash Content | ≤ 15% | Gravimetric |
| Gel Strength (LA) | > 900 g/cm² | Texture analyzer (0.5% solution) |
| Viscosity (0.5%) | 6500 – 8000 cP | Brookfield viscometer |
| Particle Size | 98% passing 60 mesh | Sieving or laser diffraction |
🦠2. MICROBIOLOGICAL STANDARDS
| Microbial Parameter | Max Limit | Test Method |
|---|---|---|
| Total Plate Count | ≤ 10,000 cfu/g | Plate count method |
| Yeasts and Molds | ≤ 400 cfu/g | Plate count method |
| E. coli | Absent | Selective agar method |
| Salmonella spp. | Absent | ISO standard methods |
⚠️ Note: Strict microbial limits ensure safety for food, beverage, and pharma use.
🧪 3. CHEMICAL PURITY AND SAFETY
- Heavy Metals: Lead ≤ 2 ppm; complies with FAO/WHO and USP/EP limits.
- Residual Solvents: Not detected or within acceptable regulatory limits.
- Endotoxins: LAL-tested (especially for injectable or ophthalmic formulations).
- Regulatory Compliance:
- Food: FDA, EFSA, GB standards
- Pharma: USP, EP, JP
- Additive: JECFA, Codex Alimentarius
📦 4. PACKAGING AND STORAGE
📦 Packaging Options:
- Multi-layer kraft paper bags with inner PE liner
- Standard net weight: 25 kg, bulk options available
- Moisture-proof and tamper-evident sealing
🌡 Storage Guidelines:
- Store in a cool, dry, and well-ventilated area
- Keep away from sunlight, humidity, and strong odors
- Shelf life: 24 months from production if sealed properly
🧾 5. DOCUMENTATION AND CERTIFICATIONS
Each shipment includes the following documents:
- ✅ Certificate of Analysis (CoA)
- ✅ Safety Data Sheet (SDS)
- ✅ Certificate of Origin
- ✅ Halal & Kosher certificates (upon request)
- ✅ Technical Data Sheet (TDS) (available upon request)
🔎 6. IN-HOUSE QUALITY TESTING PROTOCOLS
- 📌 Raw Material Inspection – Every lot of raw material is verified for compliance
- 📌 Batch-to-Batch Consistency – Confirmed by gel strength and viscosity testing
- 📌 Random Microbiological Screening – For all finished goods
- 📌 Full Traceability – Through batch codes and lot numbers
📈 Summary
CINOGEL BIOTECH implements rigorous quality control to ensure that each batch of gellan gum adheres to the highest industrial, regulatory, and safety standards. This commitment guarantees product reliability for critical applications in:
- 🥣 Food & Beverages
- 🧫 Biotechnology & Plant Tissue Culture
- 💊 Pharmaceuticals
- 💄 Cosmetics
