Regulatory-compliant processes throughout the lifecycle
From Lab to production
Setting secure standards for the future from the outset
Making the journey from lab to high output, from approval to market success, as smooth as possible: This is also ALL YOU NEED. With our expertise and machine portfolio, we enable you to successfully scale-up, to ensure seamless and efficient transition to the next production stage of your product or device. A crucial factor here: interdisciplinary collaboration between research, development, and mechanical engineering at Harro Höfliger, from the very start. All project managers are in close communication and look critically at the core processes from their different perspectives. This helps minimize the technical risk as early as in the lab phase, with each process step designed to ensure successful validation. Our systems for the lab and approval phases form the technological basis here.
Scale-up for your product
For example: powder dosing using a drum filler
Testing and optimizing – The Drum TT lab table-top device with drum filler for reproducible dosing of very small quantities starting from 0.5 mg, designed for testing and optimizing powder formulations in pharmaceutics.
Dosing and checking – the Drum Lab semi-automatic system for dosing powder into primary packaging such as capsules, vials, syringes, or blisters. With a load cell for mass control and recording results in accordance with 21 CFR Part 11.
Semi-automatic dosing – powder dosing with an Omnidose for clinical testing samples and small series using a drum filler. A patented trolley concept for the dosing stations enables a quick changeover between different methods.
Micro-dosing and more – forming, filling and sealing blisters with an SSP2 in a continuous process. For entry into fully automated production and the integration of downstream processes such as assembly and final packaging.
All-round support
From feasibility to production readiness
You may have an approved API, but lack sufficient know-how for processing your new generic drug? Or you have developed an innovative device that needs to be optimized for industrial production? Or you simply lack the equipment to conduct trials with the original product under future environmental conditions? The experts from our Pharma and Device Services team provide all-round support. Through to qualification and validation with GMP-compliant evidence that our systems consistently manufacture a product that conforms to specifications. Your product.
