Full-service Development: development,validation, transfer, stability


Galenic development

Specializing in contract manufacturing, Unither ensures that its innovative galenic forms remain competitive, practical and easy to use for the patients. The development of those galenic formulations for pharmaceutical use aims to improve the lives of patients and doctors. Unither focuses on the development and manufacture of quality single-dose drugs using Blow-Fill-Seal (BFS), Preservative-free multidose (PFMD) and liquid stick-packs technologies.

Ideal for active patients’ lifestyles, unit doses are dosage forms that are both easy to carry and administer as treatment products, thus significantly improving not only dosage accuracy but also patient compliance and treatment experience.


Primary packaging

  • Blister packs (PVC/ALU, PVC-PVDC/ALU, ALU/ALU, Aclar, Triplex)
  • Stick packs and sachets filled with liquid or powder
  • Rigid tubes for tablets, flexible HDPE tubes, aluminum tubes for topicals
  • Pillboxes

Analytical development

Analytical testing constantly assesses the product quality from development to final release.

Our team comprises over 20 analytical experts using regularly maintained, updated, and qualified equipment to perform the following services:

  • Analytical Methods Development and Validation
  • Analytical Methods Transfer
  • Storage in ICH and WHO recommended climatic chamber conditions (10 suites with all ICH zones including semi-permeable and light exposure stress conditions)
  • ICH Stability Testing for expiration and holding date/time definition
  • Quality Control for QP Release
  • Extractable and Leachable closure system compatibility studies
  • Unknown substances identification and characterization (Using LC-Mass spectroscopy)


Analytical development

  • More than 20 HPLC (Agilent and Waters) equipped with several types of detector such as DAD, refractometer and multi wavelengths detectors
  • 2 UPLC-DAD (screening of analytical methods and Quality Control)
  • 1 H-Class, 1 GC and 1 UPLC/MS coupled system
  • 8 Dissolution testing apparatus SOTAX (on-line UV or HPLC, off-line, flow-through cell USP type IV)
  • IR (FT-IR) detection
  • Karl Fisher, Coulometer, Potentiometer
  • Metered dose inhaler tester

Galenic development

  • Blenders, mixer/granulators, ovens, fluidized bed dryer, roller compactor, grinder, calibration sieves
  • Tablet compression on alternating or rotary presses (single or multi punches, mono or bi-layer tablet press)
  • Tablet coating by conventional or perforated coating pan
  • Capsule filling by manual, semi-automatic or automatic filling equipment with pre-compression
  • Mixing tanks for liquids and pastes, vacuum-jacketed tank

ICH Stability Programs

Qualified ICH climatic chambers equipped with recording systems and security alarms provide:

  • Climatic zones I, II, III, IV
  • Reduced humidity for semi-permeable products
  • Sun-test for photo-stability testing.

Crystal software provides sample handling with 100% traceability of entry and removal of stock.

Storage of products is provided as a stand-alone service and may or may not include the analysis package. Climate controlled and regular shipping services are available.

ICH Climatic Storage Capacity

ICH climatic chambers

Please move the table from left to right
Conditions Volume in m3
25°C/60% RH 41
25°C/40% RH 23
30°C/65% RH 27
30°C/70% RH 6
30°C/75% RH 16
30°C/35% RH 5
40°C/75% RH 27
40°C/25% RH 3
5°C 2
-20°C 0.5

Production of commercial batches

Regulatory expertise