Aseptic preparations

AMPOULES AND PRE-FILLED SYRINGES

IHRE APOTHEKER package pharmaceutical injection solutions under sterile conditions: sterile, controlled and fast. We also support our customers in complying with the requirements governing filling liquid medication into ampoules and pre-filled syringes – during development, clinical testing and commercial application.

WHAT WE OFFER

  • Manufacturing licence in accordance with § 13 AMG (German Medicines Act) and GMP
  • Class A/B clean room laboratories equipped with state-of-the-art technology and optimum air conditioning
  • Batch manufacture of injection solutions incl. weighing the base materials
  • Aseptic filling of ampoules and pre-filled syringes with sterile filtration or stabilisation in final receptacles
  • Initial, in-process and final inspections in our own modern laboratories
  • Pharmaceutical support in developing injection solution products, e.g. clinical testing
  • Selection by our own specialist pharmacy personnel and speedy delivery thanks to our own logistics system

OUR COMMITMENT

Our modern filling methods featuring sterile filtration into the final receptacle for thermo labile products as well as GMP-conformant documentation means that IHRE APOTHEKER avail themselves of all of the requisite resources for supplying patients with pre-filled sterile ampoules and syringes.

The manufacture and filling of sterile injection solutions is governed by special statutory requirements in order to minimise the risk of contamination with micro-organisms, particles and pyrogens. Much is dependent on the skill, training and conduct displayed by the respective specialist personnel as well as the spatial conditions.

We attach particular importance to quality assurance and production is strictly subject to methods and processes which have been carefully specified and validated, whereby sterility or other quality aspects are not merely based on the last manufacturing stage of inspection of the final product.

YOUR ADVANTAGE

Individual doses in pre-filled ampoules and syringes improve medical care from various perspectives. Ampoules and pre-filled syringes sterilised in the final receptacle have an essentially longer shelf life than aseptic products. We examine substance mixtures for chemical and physical stability and can offer shelf lives of up to one year for individual formulations. The advantages involve minimising microbial contamination as well as easy handling and use, especially of pre-filled syringes. Optimised operations thanks to individual solutions also translate into lower costs and expense for you accompanied by increased flexibility and planning security.