Inhalation Testing Laboratory
Inhalation testing laboratory of Enem Nostrum is well equipped with innovative instruments with two separate laboratories to carry out developmental work and cGMP compliant work.
With the help of expert Scientists, Laboratory is continuously moving towards innovative approach for Inhalation Techniques to carry out Inhalation Testing.
Inhalation testing laboratory provides intense analytical Services to our clients. Our experience in inhalation techniques is ideally suited to meet all of your needs.
Features:
Expertise in
- ‘In-Vitro’ Inhalation Techniques like
- - Aerodynamic Assessment of fine Particles by Andersen Cascade Impactor, Glass Twin Impinger for MDI’s & DPI’s
- - Delivered Dose Uniformity by Dosage Unit Sampling Apparatus for MDI’s & DPI’s
- - Drug Substance Delivery Rate and Total Drug Substance Delivered by Breath Simulator for Nebulizers
- Assay and Related Substances for Inhalation Products
- Characterization tests for Spacers and Valved Holding Chambers used with Inhalation Aerosols
- Method Development & Method Validation of different inhalation techniques i.e. fine Particles by Andersen Cascade Impactor and Twin Impinger, Delivered Dose Uniformity by Dosage Unit Sampling Apparatus, Drug Substance Delivery Rate and Total Drug Substance Delivered by Breath Simulator for different Inhalation products.
- Evaluation of drug delivery devices like Valved Holding Chambers, Spacers, Nebulizer devices, MDI Actuators, etc.
- Stability study of different drug delivery devices and inhalation formulations under controlled temperature and humidity conditions as per customer requirements.
- In addition, Inhalation Testing laboratory is also facilitated with Particle Size analysis by Laser Diffraction technique for different formulations like dry powders, suspensions, Metered Dose Inhalers, Nebulizers, Nasal Sprays, etc.
Key Equipments and Instruments
Our laboratory is well-equipped with following Equipments / Instruments
- Andersen Cascade Impactor (Copley Scientific)
- Glass Twin Impinger (Copley Scientific)
- Breath Simulator (Data M Engineering)
- Dosage Unit Sampling Apparatus for MDI’s & DPI’s (Copley Scientific)
- Laser Particle Size Analyzer (SympaTec – HELOS BR H2220) with different dispersing units
Particle Size Analyzer (SympaTec)
A powerful technology for particle size analysis with different dispersing units
- Sprayer - for Nasal Sprays at multi angle use
- Cuvette - For wet dispersion like suspensions and emulsions with small sample volume
- Sucell - For wet dispersion analysis
- Rodos with Vibri – for dry powder analysis
- Rodos with Aspiros – for dry powder analysis with micro-dosing unit for small sample quantity
- Inhaler- For Metered Dose Inhalers, Dry Powder Inhalers, Nebulizers
