Sterile manufacturing & validation – safety for your aseptic processes
Sterile/aseptic manufacturing processes require absolute process control and complete documentation of effectiveness.
Valmonas Analytik AG supports you with GMP-compliant testing programs – from qualified equipment control to practical simulations.
Our goal: Maximum safety and compliance with standards for your aseptic production.
Our performance promise
Certified testing according to GMP and EU Annex 1
Practical qualifications & validations with realistic loading and process scenarios
Complete, audit-proof documentation for audits and authorities
Individual project planning tailored to your production environment
Our services at a glance
Autoclave qualification / isolator validation
Create plan and risk analysis
Determining the placement of biological and chemical indicators
Incoming inspection of biological indicators according to the current monographs EP 5.1.2
and USP <55>
Incubation and evaluation of biological indicators
Create report for insulator validation
Media Fill (Aseptic Process Simulation)
Implementation in accordance with Annex 1 and customer-specific SOPs
Temperature controller transport
Incubation over defined periods under GMP conditions
Evaluation and microbiological testing of the filling batches
Complete documentation including results report
Project progress
Analysis & Planning – Gathering your requirements, creating the validation plan
On-site execution – by qualified Valmonas specialists under GMP conditions
Laboratory analysis & evaluation – examination of indicators, samples and simulation results
Documentation & Handover – Reports with clear assessment and recommendations for action
Follow-up – Support for re-validations and optimization projects
Advantages with Valmonas
Swissmedic-GMP certified laboratory
Extensive experience in the validation of aseptic process systems
Precise measurement and testing methods according to international standards
Punctuality, high flexibility and personal support