Subvisible particles
Ph.Eur. 2.9.19. PARTICULATE CONTAMINATION: SUB-VISIBLE PARTICLES
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METHOD 1, Light Obscuration Particle Count Test
- METHOD 2, Microscopic Particle Count Test; Combination of required conditions as claimed in Ph.Eur. 2.9.19
The method is performed by a microscope with motorized stage and camara system (GMP-qualified).
Parenteral Nutrition
- Already developed lipid emulsion with granted marketing authorization
- Based on experience, stability testing of all in one-systems and three-chamber bags
- Justification of specification
Manufacturing License for Drilling and Stuffing of Tablets used in Clinical Studies
- Procurement of Reference Medicinal Products
- Manufacturing under GMP-conditions for use in Magnetic Marker Monitoring (MMM) – studies
- Analytical support regarding dissolution testing, assay and on-going storage during the time-frame of clinical study
- QP-release for clinical studies
PDF-pages of our Manufacturing and Import License