We develop and validate a range of analytical methods. Specialist facilities include New Generation Impactor (NGI) and Andersen Cascade Impactor (ACI), and techniques are employed to test for Delivered Dose Uniformity (DDU); Impurities; Ethanol Content; Leak Rate; Moisture. These techniques would be employed to conduct the full range of Product Characterisation studies required for licence submission. We offer full stability testing and storage on site, including stability cabinet management.
We have the capabilities and expertise to develop both Solution and Suspension formulations. Our facilities allow laboratory scale and pilot scale production, for volumes from 5l to 100l, capable of delivering Two Stage, Single Stage or Dual Shot filling processes.
Our HFA MDI manufacturing facility is capable of handling various dosage forms – Solutions, Suspensions, Inhalation, Sub-lingual – and employing Single Stage, Two Stage and Dual Shot filling processes. The lines include check weighing and bulk packaging facilities, and in addition we have a discrete secondary packaging area.
We have the capability together with extensive know-how to develop DPI products in capsule and blister based devices. Our expertise can achieve performance aligned with target product profile (i.e. for a generic product we can develop a formulation or device combination with performance to match the reference branded product both in-vitro testing and in the clinic). We can use lactose blend base formulation with various APIs in single or combination base units. Small and pilot scale manufacturing can be carried out using a variety of blending and filling equipment. Access to alternative devices to the above is also available.
We can develop and validate a full range of analytical methods for DPI performance testing. Capabilities include New Generation Impactor (NGI) and Andersen Cascade Impactors (ACIs) and techniques employed to test for Assay, Impurities, and Moisture. These techniques would be employed for Product Characterisation studies and pre and pivotal stability studies. Material characterisation can be progressed to evaluate raw material characteristics to understand the relationship to the product performance.
We have two GMP suites available for potential commercial manufacturing of DPIs.
We are experienced in the development of Nasal spray formulations utilising a wide variety of container/closure systems. Process development is conducted on site utilising commercial equipment or essentially similar equipment to ease the transfer to large scale.
Method Development and Validation. Testing capabilities include Assay; Impurities; DDU; preservative assay. Utilisation of these methods to conduct Product Characterisation and pre/pivotal/post stability studies
The facility can produce Solutions, Suspensions, Pump Sprays and Liquids, employing both Low Shear Mixing and High Shear Mixing manufacturing processes. Packaging capabilities include tamper evident label application, leaflet insertion and packaging.
PSNW is experienced in the development of liquid formulations utilising a wide variety of container/closure systems. Process development is conducted on site and will be conducted to lead into the commercial capabilities on site.
Development and validation of standard testing techniques to cover assay, impurities, preservative assay etc.
The facility can produce Solutions, Suspensions, Pump Sprays and Liquids, employing both Low Shear Mixing and High Shear Mixing manufacturing processes. Packaging capabilities includes tamper evident label application, leaflet insertion and packaging.