How quickly can validatable product changeovers be carried out in a pharmaceutical powder mixing plant?
The duration of such changeovers depends strongly on various factors, including plant design, cleaning strategy, containment level, product criticality and the release process. In practice it ranges, depending on the system, from a few hours to a complete shift or even longer.
Typical guide values
Highly automated, hygienically designed plants with good hygienic design, automated cleaning and efficient analytical release often allow product changeovers within a few hours.
Containment-optimised systems
Where the system is designed for rapid cleaning, short dismantling times and low residues, the mechanical part of the changeover can be completed very quickly. The total time is then frequently determined more by drying, sampling and QA release than by the actual conversion work.
Conventionally cleaned plants
With manual dismantling, complex geometry or high containment requirements, markedly longer changeover times are usual, particularly where extensive laboratory analysis is also required.
What influences the time most
- Cleaning strategy: automated, semi-automated or manual.
- Plant design: minimal dead space, accessibility, surface quality and drainability.
- Containment requirement: the more critical the dust or the active ingredient, the more elaborate the changeover.
- Analysis and release: rapid methods shorten the waiting time, classical laboratory analysis lengthens it.
- Drying: after wet cleaning it is often not the cleaning itself but complete drying that determines the time.
In practice
A blanket figure in hours is of limited reliability. What matters is not the mechanical cleaning time alone but the time until the line is fully released, including documentation, sampling and QA review. It is precisely this total time that should be demonstrated for the specific plant as part of the cleaning validation.
How amixon® shortens product changeover and cleaning times with a hygienic design
The most efficient cleaning step is complete discharge
At amixon®, the product changeover begins with almost complete discharge: free-flowing materials discharge from conical mixers (AM) and from the KoneSlid® mixer (KS) to 99.997 % and better. In vertical mixers (VM, HM), ComDisc® elements discharge the last residues without segregation. In the HM environment, 99.997 % and better has been achieved. Whatever has already left the mixer does not have to be cleaned. This immediately reduces the cleaning time as well as the use of water and detergent.
Dry changeover: accessibility is decisive
The large Clever-Cut® inspection doors with the OmgaSeal® seal allow ergonomic access to all product-contact surfaces. The mixing chamber, welded free of crevices and ground smooth, without dead spaces and without a lower shaft passage, can be dry-cleaned quickly and safely. In the KoneSlid® KS, all parts are expressly accessible for manual dry cleaning. Dry cleaning is very rare in pharmaceutical factories.
Wet changeover: CIP/WIP through to automation
For validated wet changeovers – for example with allergens or when changing from savoury to sweet – washing lances are integrated. On request, amixon® supplies fully automatic wet cleaning. WaterDragon® can accommodate freely programmable target-jet nozzles. Vacuum mixer-dryers and large mixers in solid dosage form production are a reference example from practice.
Realistic changeover times depend on the product and can be demonstrated in advance
Reliable time data depend on the product (does it adhere, form crusts, stain?), on the cleaning regime and on the drying requirement. amixon® determines the actual changeover times with the original product at the pilot plant – as a robust basis for OEE planning and capacity calculation before the investment is made.
For pharmaceutical applications, amixon® supplies the apparatus in GMP-compliant form: usable in FDA-compliant form as sterile mixers/reactors, EHEDG- and 3-A-compliant, with assistance on request for DQ/IQ/OQ and documentation to EU GMP and FDA 21 CFR Part 11 – every apparatus a one-off to the URS.
Manufacture in Paderborn as the quality foundation
amixon® develops and manufactures exclusively at the Paderborn works – with the greatest depth of fabrication and all components from Germany. As a certified welding company with European, Japanese, Korean and American qualifications, amixon® designs every apparatus as a one-off on the basis of the operator's URS. Quality control remains entirely in-house without gaps and every specification is verifiable down to component level. This manufacturing autonomy also secures long-term supply. Every component can still be re-manufactured reproducibly decades later.
Product protection as a system property
amixon® mixers operate at low speed: the circumferential speed of the tools is adjustable between approximately 0.8 and 3.5 m/s; mixing takes place via the SinConvex® mixing helix – upwards at the periphery, downwards under gravity in the centre – without throwing, impact or crushing zones and without appreciable heat input. Sensitive structures, coatings and agglomerates are preserved. Where targeted de-agglomeration is required, switchable cutting rotors act in a locally limited manner without stressing the entire batch.