The Benefits of the Laboratory Scale Mill

Cost Effectiveness

Developing a new product can be expensive, with research and development taking time and money before the actual formulation of a drug can begin.  When it comes to equipment procurement, the M05-U permits a cost effective piece of equipment to allow the development of a drug before committing to larger and more expensive machinery.  It is fundamentally important to be sure a new product is viable before proceeding to capital procurement, and development of a new production suite.

Size

The M05-U is designed for small scale labs, and other small areas where space is at a premium.  At only 35kgs and basic dimensions of…. The M05-U is ideal for both small scale applications, and for use in research and development labs.  Often at the beginning of development, only small amounts of expensive and time consuming material may be available.  Able to handle small batches of material (down to 100 grams), the M05-U is ideal for early stages of product development when large amounts of material to test are not available.

GMP Design

The M05-U is designed to GMP standards, 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. 

Scaleability

The Hanningfield range of under-drive 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 scaleable RPM.  The M05-U allows the user to work out issues with any product which may come up 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 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 lots of parameters

To create the perfect 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.