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Premium Freeze-Dried Powder Manufacturing
Pharmaceutical-Grade Lyophilization Services for Probiotics, Enzymes, Collagen & Botanical Extracts
Years Experience
Projects Completed
ISO 8 Cleanroom
Countries Served
Three-Tier Freeze-Drying Solutions
BioFreeze specializes in custom lyophilization services across pharmaceutical, food, and cosmetic industries. Our ISO 8 cleanroom facility processes temperature-sensitive biologics with precision temperature control from -80°C to +40°C.
Pharmaceutical Grade
GMP-compliant freeze-drying for probiotics, enzymes, vaccines, and biologics. FDA-registered facility with full documentation support for regulatory submissions.
- Probiotic powder (10-500 billion CFU/g)
- Enzyme formulations (protease, lipase, amylase)
- Peptide and protein stabilization
- Vaccine and biologic processing
- Complete CoA and stability testing
Food Grade
HACCP-certified processing for fruit powders, vegetable extracts, and nutritional supplements. Preserves natural color, flavor, and nutritional value.
- Fruit & vegetable powder (strawberry, blueberry, kale)
- Instant coffee and tea extracts
- Nutritional supplement ingredients
- Organic certification available
- Custom flavor development
Cosmetic Grade
Premium lyophilization for collagen, hyaluronic acid, and botanical extracts. GMPC-compliant production for high-end skincare formulations.
- Marine & bovine collagen peptides
- Hyaluronic acid powder
- Plant stem cell extracts
- Anti-aging active ingredients
- Halal & Kosher certification
Why Leading Brands Choose BioFreeze
Our pharmaceutical-grade freeze-drying facility combines advanced lyophilization technology with rigorous quality control. Every batch undergoes comprehensive testing to ensure product stability, potency, and safety.
ISO 8 Cleanroom Facility
130m² pharmaceutical-grade cleanroom with HEPA filtration, positive pressure control, and continuous environmental monitoring. Class 100,000 (ISO 8) certification ensures contamination-free processing for sensitive biologics.
Advanced Lyophilization Equipment
State-of-the-art freeze dryers with programmable temperature control (-80°C to +40°C), vacuum systems (0.01-1.0 mbar), and automated cycle monitoring. Capacity ranges from 10kg to 500kg per batch.
Comprehensive Quality Testing
In-house analytical laboratory equipped with HPLC, GC-MS, microbial testing, and moisture analysis. Every batch includes Certificate of Analysis with full traceability and stability data.
Regulatory Compliance
FDA-registered facility with ISO 13485:2016, cGMP, and HACCP certifications. Complete documentation support for regulatory submissions in USA, EU, Japan, and other markets.
Custom Formulation Development
Experienced R&D team provides formulation optimization, stability testing, and process validation. Free sample testing and pilot batch production before full-scale manufacturing.
Flexible Production Capacity
Scalable production from 10kg trial batches to 2000kg monthly capacity. Fast turnaround time (2-3 weeks) with priority scheduling for urgent orders and seasonal demand.
Professional Freeze-Drying Workflow
From raw material receiving to final packaging, every step follows strict GMP protocols. Our quality management system ensures consistent product quality and full batch traceability.
Material Receiving & Inspection
Raw materials undergo identity verification, purity testing, and microbial screening. All ingredients are stored in temperature-controlled warehouses with real-time monitoring.
Formulation & Pre-Treatment
Precise weighing and mixing in cleanroom environment. Solution preparation with pH adjustment, stabilizer addition, and sterile filtration as required.
Controlled-Rate Freezing
Programmable freezing from +20°C to -40°C at optimal cooling rates. Prevents ice crystal formation and maintains product structure integrity.
Primary Drying (Sublimation)
Vacuum application (0.01-0.1 mbar) with gradual temperature increase. Ice crystals sublimate directly to vapor, removing 90-95% of moisture content.
Secondary Drying (Desorption)
Temperature elevation to +20°C to +40°C removes bound water molecules. Final moisture content reduced to <3% for optimal stability and shelf life.
Quality Control & Testing
Comprehensive analysis including moisture content, water activity, particle size, microbial count, and active ingredient potency verification.
Packaging & Storage
Nitrogen flushing and hermetic sealing in aluminum foil bags or HDPE bottles. Storage in climate-controlled warehouse until shipment.
International Certifications & Standards
BioFreeze maintains the highest quality standards recognized globally. Our certifications demonstrate commitment to product safety, efficacy, and regulatory compliance.
Medical Devices QMS
Quality management system for medical device manufacturing. Ensures consistent product quality and regulatory compliance for pharmaceutical applications.
Class 100,000 Facility
Controlled environment with <100,000 particles (≥0.5μm) per cubic meter. HEPA filtration and positive pressure prevent contamination.
Current Good Manufacturing Practice
FDA-compliant manufacturing processes with documented procedures, batch records, and quality control protocols.
Food Safety Management
Hazard Analysis Critical Control Points system for food-grade products. Ensures safety from raw material to finished product.
Religious Certifications
Certified production processes meeting Islamic and Jewish dietary requirements. Available for qualifying products upon request.
US Market Access
Registered with US Food and Drug Administration. Enables direct export to American market with full regulatory compliance.
Trusted by Leading Brands Worldwide
Our clients range from startup nutraceutical companies to multinational pharmaceutical corporations. Read what they say about our freeze-drying services.
Industries We Serve
BioFreeze freeze-dried powders are used across multiple industries requiring high-quality, stable, and bioavailable ingredients.
Pharmaceutical & Biotechnology
Vaccine stabilization, enzyme formulations, peptide drugs, probiotic therapeutics, diagnostic reagents, and biologic APIs.
Nutraceuticals & Supplements
Probiotic supplements, enzyme blends, protein powders, vitamin complexes, herbal extracts, and functional food ingredients.
Food & Beverage
Instant coffee, fruit powders, vegetable extracts, flavor concentrates, soup mixes, and emergency food supplies.
Cosmetics & Personal Care
Collagen peptides, hyaluronic acid, plant stem cells, anti-aging actives, and botanical extracts for premium skincare.
Animal Nutrition
Pet probiotics, enzyme supplements, palatability enhancers, and veterinary pharmaceutical ingredients.
Research & Development
Custom lyophilization for research institutions, universities, and biotech startups developing novel formulations.
Start Your Freeze-Drying Project Today
Contact our technical team for a free consultation. We’ll analyze your product requirements and provide a detailed proposal including process parameters, timeline, and pricing. Sample testing available for qualified projects.
Response time: <24 hours | Technical consultation: Free | Sample testing: Available