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We offer inhalation development and manufacturing services for Pressurized Metered Dose Inhaler (pMDI), nasal sprays and respules for nebulization. Our services are backed by analytical services including method development, validations, technology transfer and stability studies as per ICH guidelines.

 

Equipment for Analyzing Drug and Device Combination

  • Cascade Impactor - Next Generation Impactor (NGI) with induction port and expansion chamber
  • NGI Rocker
  • NGI Cooler
  • Sampling apparatus for MDI
  • Flowmeter
  • DUSA Shaker for MDI
  • Breath Simulator BRS 2000
  • Sprayview
  • Spraytec

 

Analytical R&D Capabilities Include:

  • Characterization of physicochemical properties of drug substance and drug product
  • Stability indicating method development for quantification of assay and related substances (impurities)
  • Support for short term temperature exposure studies and regular stability studies as per ICH (long term, intermediate and accelerated conditions)
  • Method validations in accordance with ICH guidelines / customer-specific requirements
  • Method transfer to QC laboratory by demonstrating method is operational by performing the system suitability and batch analysis

 

Inhalation Product Development and Manufacturing Services

 

Metered Dose Inhaler Manufacturing Capacity

  • Fill volume range: 1 ml to 19 ml
  • Minimum batch size: 50 L
  • Maximum batch Size: 250 L
  • Yearly output: 100 batches (2,000,000 canisters)
  • Canister type: Aluminium canisters (coated and uncoated)
  • Capable to fill all types of metered valves (Aptar, Bespak & 3M)
  • Stress test of filled canister shall be done by using water stress test bath
  • Valve functioning checking by using lac test machine
  • Online check-weighing and coding of the filled canister
  • Ability to handle popularly used HFA’s -227 and 134a

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

Nasal Spray Inhaler Manufacturing Capacity

  • Fill volume range: 1 ml to 52 ml
  • Minimum batch size: 50 L
  • Maximum batch size: 1600 L
  • Yearly output: 90 batches (9,000,000 canisters)
  • Container type: Bottles (plastic and glass)
  • Container closure: Crimp, snap and screw fit
  • Water for Injection and dedicated autoclave are available

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