The heart of the new unit: the pharmaceutical-type container blender

The heart of the new unit: the pharmaceutical-type container blender.

The blender works on the counter-current principle

The blender works on the counter-current principle.

Physical separation for optimum hygiene

Physical separation for optimum hygiene.

Barcode-controlled production process

Barcode-controlled production process.

Metal detection during filling process

Metal detection during filling process

Our GMP-certified counter-current container blending unit for highly sensitive products sets new standards – not only in Germany.

Officially certified plant

After successful qualification of our counter-current container blending unit and validation of the relevant cleaning process according to Part II of the EU GMP Guide / ICH Q7, SternMaid is now able to produce pharmaceutical blends of chemical active ingredients and excipients with GMP certification.
From May 2012 the company’s range of services will be complemented by a prospectively qualified and validated fluid bed dryer.

Maximum safety for highly sensitive products

Products like baby food, food supplements, vitamin mixtures or chemical active ingredients and excipients for the pharmaceutical industry make exceptional demands on production technology. Our new blending plant for these highly sensitive products ensures maximum safety, traceability and purity. The heart of the new factory is the pharmaceutical container blender. Special solutions in the fields of mechanical and control engineering were achieved in collaboration with the component suppliers.

Compounding without residues

Assuming that extreme care has been taken in the choice, production and transportation of the raw materials, we can now compound allergen-free products. The mixing and filling of clear soluble vitamins for the fruit juice industry presents no problems either.

To ensure optimum hygiene in the new plant, the individual production steps are separated physically. For example, there are separate rooms for depalletizing, weighing, feeding of the products, blending, sifting, filling and palletizing in three different hygiene zones. In addition there are cleaning and changing rooms, staff recreation rooms, hygiene air locks, a technical control room and a production office. The cleaning process was validated with the introduction of GMP.

Optimum batch traceability

In the new unit the entire process is capable of validation. All additions of products can be scanned in by means of an EDP program during weighing in the feeding room. That means it is possible to tell, at any time, which raw material from which batch is in which blending container.

Blender with special equipment for substances difficult to blend

The blender works on the counter-current principle, using a free fall method that ensures extremely gentle processing of the raw materials. The blending takes place in a rotating container turning at no more than six revolutions a minute, thus reducing mechanical damage to a minimum. In order to ensure fully homogeneous mixing even with substances that are difficult to blend, the unit has a specially designed feature: if necessary, a cutter can be inserted into the lid of the container. A frequency regulator adjusts the speed of this breaking device in such a way that even particles of extremely different sizes can be mixed with optimum results.

Facts and figures

  • Applications:
    Production of extremely sensitive blends such as baby food, food supplements, vitamin mixtures and OTC products, chemical active ingredients and excipients for the pharmaceutical industry.
  • Process technology:
    Qualified plant; all parts designed to pharmaceutical standards; entire process capable of validation; scanner recording of each substance added; threefold certainty in the weighing procedure achieved by a counterchecking method; precise batch separation.
  • Blending system:
    Counter-current container blending unit; gentle handling of the contents at a maximum of 6 r.p.m.; gross volume: 2,200 litres; average batch size: 800–1000 kg; additional options: cutter head in the lid for finer distribution of the particles; addition of liquids by means of special dosing equipment.
  • Batch sizes: 200 to 1,000 kg
  • Floor area: 700 m²
  • Blending capacity: 4,000 tonnes p.a.
  • Hygiene:
    Contamination-free; unit can be wet-cleaned throughout; three graduated hygiene areas
  • Filling options:
    Fibreboard boxes with different liners, e.g. composite aluminium foil bags or contamination-free filling into continuous tubular bagging welded immediately at the filling site; optional treatment with protective gas; filling in big bags; filling in sacks