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.

General


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.

Technical Specifications


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

Operating Characteristics


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

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Product type Characteristics


Product Types
Dry sterile product,oral solid dosage,API material


21 CFR Part 11 compliance
Yes
Annex 11 compliance
Yes
USP 922
Yes

Physical Characteristics


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

Custom Options


Glass Type
tubing and molded