The Benefits of the Laboratory Scale Mill

Cost Effectiveness

Developing a new product can be expensive, with R & D taking time and costing money before the actual formulation of a drug can begin. The Hanningfield M05-U proves to be a cost-effective piece of equipment, enabling the development of a drug on a smaller scale before committing to larger and more expensive machinery. 

Size

The M05-U is designed for small scale laboratories where space is at a premium.  At only 35 kgs and with its small dimensions, it is ideal for small scale applications and for use in R & D labs.  Often at the beginning of development, only small amounts of material may be available.  With the ability to handle these small batches (down to 100 grams), the M05-U is suitable for the early stages of product development when large amounts of material are not yet available.

GMP Design

The M05-U is designed to GMP standards and suitable for pharmaceutical applications.  The material contact parts of the M05-U are 316L (EN 1.4404) and 304 (EN 1.4301) as standard, with 180 grit  (0.76μm) and 150 grit (1.06μm) respectively.  Surfaces are designed to be easily cleaned with minimal dust trap areas.  All non-metallic contact parts are FDA compliant. 

Scalability

The Hanningfield range of under-driven conical mills, from M05-U to M30-U, maintain a consistent design, consistent screen angle, gap between impeller and screen, consistent tooling (same impeller bar design and screen availability) and scalable RPM.  The M05-U allows the user to work out issues which may arise once the product has moved into pilot or production scale.  At a molecular level, the structure of the API and its coagulant is imperative to ensure the product flows easily through the various stages of a wet or dry granulation process.  Milling of blended API and coagulant can help to alter the structure of the particle to a more spherical shape, which when scaled-up, will help the material to flow better, and at tabletting stage to compact better with the particles surrounding it.  Testing and working out any issues at the lab-scale stage, will allow for greater confidence when purchasing production scale equipment.    

Ability to Test Multiple Parameters

To create the desired product, various parameters must be tested to see which gives the best results, generally speaking this would be particle size.  As standard, the M05-U is supplied with a variable speed drive, running as low as 100 RPM up to 6000RPM, giving a vast range of impeller speeds to test, exhibiting different effects on the material being milled.  A variety of tooling is available, with over 40 screens of differing hole sizes, open areas, and hole types, and also several impeller bars, allowing the operator to explore which screen, impeller and RPM give the best results.  Hanningfield will also give guidance on the optimum screen and impeller selection, based on application and material details provided by the customer.

If you are developing a new product for release, or just have a small scale operation where production scale machinery isn’t necessary, the M05-U is an ideal solution.