Stason Industrial Corporation

Overview

Stason Industrial Corporation is a US-based contract development and manufacturing organization (CDMO) headquartered in Southern California. The company entered the commercial generic market in 1994 and has expanded to offer comprehensive contract manufacturing and analytical services to drug-development companies ranging from virtual start-ups to top-20 pharma companies.

Core Services

Manufacturing Capabilities:

• Solid dosage forms (tablets and capsules) with capacity exceeding 2 billion oral doses per year
• Batch size capacity from 0.5 kg to 600 kg
• Injectable and liquid manufacturing through partnership with Standard Chem. & Pharm. Co. Ltd. in Taiwan (lyophilization, suspension, powder filling)
• Semi-solid dose formulations (bench-top through Phase 2 clinical trial production)
• Packaging services: automatic encapsulation (50,000 capsules/hour), automatic packaging lines (up to 100 bottles/minute), unit dose blister design and development

High Containment Operations (HCO):

• Closed manufacturing system handling highly potent compounds down to occupational exposure level (OEL) of 0.1 µg/m³ or less
• Multiple dedicated processing suites with dedicated packing room, remote data acquisition system, and documentation room
• Segregated facility with 40 air changes per hour
• SafeBridge® Category 1-4 compound handling

Quality Control & Stability Testing:

• QC testing for Active Pharmaceutical Ingredients (APIs), pharmaceutical intermediates, excipients, and finished products
• ICH-compliant stability chambers (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, and customized conditions)
• Long-term, accelerated, comparative stability testing and forced degradation studies
• Full generator backup for environmental chambers

Facility Infrastructure:

• Irvine, California manufacturing facility: ~37,000 sq. feet in sprinkler-equipped concrete building
• Class 100,000/ISO Class 8 clean rooms with 12-foot minimum ceilings
• Temperature control: 18–24°C with minimum 20 air changes per hour (standard operations) and 40 changes per hour (high-containment)
• cGMP-compliant quality control systems with strict adherence to regulatory requirements

Regulatory & Compliance

Stason complies with all applicable environmental, occupational health and safety, public health and safety, and waste disposal regulations. The company holds all current and applicable governmental licenses, approvals, permits, and authorizations. Quality-by-Design (QbD) principles guide CMC regulatory review and manufacturing processes.