Water activity headspace analyzer for drug product samples
Ensure precise control of moisture levels across the entire product lifecycle, from development through production, to maintain product integrity and compliance during water activity analysis.
Measures Water Activity in Drug Products
The FMS-Water Activity Headspace Analyzer by Lighthouse Instruments is engineered to precisely measure the water activity in pharmaceutical substrates. Utilizing a headspace analysis method, it enables real-time moisture exchange assessments and vapor transmission studies, ensuring product integrity and stability. Essential for quality control in pharmaceuticals, it replaces traditional methods like Karl Fischer Titration with efficiency, particularly for sterile products, tablets, and lyophilized vials. Designed for versatility, it supports configurations ranging from ampoules to vials and caters to outer diameters between 10.5 to 52mm. The instrument is 21 CFR Part 11 compliant, integrating seamlessly into your laboratory workflows with automation capabilities, ensuring reliable and repeatable results. Constructed for bench-top operation, the analyzer’s material choices and compliance with industry standards make it a robust addition to any drug development or QC laboratory setting.
Benefits
- Ensures product stability by precisely controlling moisture levels in pharmaceuticals.
- Streamlines quality control processes, eliminating the need for traditional, time-consuming moisture tests.
- Enhances operational efficiency with real-time water activity analysis.
- Compliant with 21 CFR Part 11, securing data integrity and regulatory adherence.
- Adapts to various container sizes, increasing versatility in testing different product forms.
- Applications
- Powder product, Pharmaceutical tablets, Oral solid dosage forms, Drug product samples, Api material, Dry sterile product, Pharmaceuticals
- End products
- Coated tablets, Sterile injectable powders, Effervescent tablets, Lyophilized vials, Active pharmaceutical ingredients (apis), Granular pharmaceuticals, Dry powder inhalers, Chewable tablets, Capsules, Buccal tablets
- Steps before
- Formulation, Drying, Powder Mixing
- Steps after
- Quality Control, Moisture Analysis, Packaging, Product Stability Testing
- Input ingredients
- dry sterile product, oral solid dosage, API material, ampoules, vials, bottles
- Output ingredients
- water activity measurements, moisture exchange data, water vapor transmission rate data, KFT replacement data, LOD replacement data, microbial study data
- Market info
- Lighthouse Instruments is known for its expertise in providing high-precision laser-based inspection and measurement systems, primarily for the pharmaceutical industry, specializing in non-destructive testing solutions for ensuring container integrity and product quality.
- Required Headspace
- 3 mm
- Measurement Range
- 0 to 1.0 (0 to 100% relative humidity)
- Configuration Range
- 10.5 to 52 mm outer diameter
- Temperature Controller Range
- 19 to 45°C
- Glass types
- Tubing and molded
- Software Compliance
- 21 CFR Part 11 and Annex 11 compliant
- Measurement Range
- 0 to 1.0 (0 to 100% relative humidity)
- Temperature Control Range
- 19 to 45°C
- Product Life Cycle Usage
- Development to QC lab applications to at-line, in-process control
- Water Activity Determination Methods
- Replacement of Karl Fischer Titration (KFT), Loss On Drying (LOD)
- Configuration Types
- Ampoules, Vials, and Bottles
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Product Types
- Dry sterile product, oral solid dosage, API material
- 21 CFR Part 11 compliance
- Yes
- Annex 11 compliance
- Yes
- USP 922
- Yes
- Measurement Range
- 0 to 1.0 (0 to 100% relative humidity)
- Required Headspace
- 3mm
- Configuration Range
- 10.5 to 52mm outer diameter
- Temperature Controller Range
- 19 to 45°C
- Glass Type
- Tubing and molded
- Glass Type
- tubing and molded