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Contract manufacturing

As a contract manufacturer, we use our considerable technical expertise to manufacture hard capsules or powder products to your individual specifications.
We will support you at every stage in the process from product development through marketability testing to market launch. We offer excellent terms and customer focused service, short delivery times and transparent calculation of costs. Contact us for a quote and we will get back to you within 48 hours.
 

Below, we will give you an overview of our production and the options we offer for the implementation of your individual product.

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Premises

Compliant with GMP

Modern GMP compliant Class C and D premises ensure optimal conditions when handling sensitive substances. Relative humidity can be reduced up to 35 % with our centrally controlled air conditioning system.

 

Summary Premises

  • GMP compliant premises on 110 sqm
  • Centrally controlled air conditioning system
  • Fresh air exchange 25 times an hour
  • Particle separation of more than 99.995% with H14 filters

 

 

 

 

 

 

 

Weighing area

image source: ProRecipe XT®  – Rezeptursoftware, Sartorius
image source: ProRecipe XT® – Rezeptursoftware, Sartorius

Three co-ordinated, calibrated scales, which are connected by a formulation software, are used for weighing. The software-based application guides the user through the entire weighing process and ensures a uniform and reproducible batch quality and application security through the systemic monitoring and control.

 

Summary Weighing

  • 3 calibrated scales for all weighing ranges
  • Computer-controlled and GMP compliant formulation and weighing process
  • Extensive documentation

 

 

 

 

 

Mixing

Mixing.jpg

Our closed container mixing system has been specially designed for the homogeneous mixing of pharmaceutical solids with a density between 0.2 – 1.2 kg/dm3.
In the mixing process, we use rotating containers with a capacity of up to 800 L, with integrated, patented mixing blades (see drawing below). This creates counter flows in the powder flow within the container, which allows the optimal mixing of solids. It also ensures the homogenous mixing of all substances, even those in very small quantities.
There is also little mechanical stress with this procedure, which ensures a particularly gentle mixing of the raw materials at low speeds of up to 6 RPM.

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The closed system prevents contamination of the product during the process. This containment management continues at the end of the mixing process, when the mixing container is tilted directly above the capsule filling machine by an integrated hub function and discharges the product directly into the product tank of the capsule filler. This prevents segregation or contamination.

 

Summary Mixing

  • Closed container mixing system
  • Homogeneous and at the same time gentle mixing process
  • Containment system during the product transfer
  • GMP compliant

 

 

 

 

 

 

 

Capsule filling

Dosing system via compression
Dosing system via compression

The capsule production uses a computer controlled, high-end capsule filling machine, with a capacity of up to 100,000 capsules per hour. The high flexibility of the machine allows the cost-effective production even of small batches from 50,000 capsules. A special feature of the machine is the combination of a proven capsule filling technology with an innovative design that allows a particularly efficient filling of hard capsules. To fill the small capsules with as much power as possible, the powder is compacted in the machine under vacuum and then pressed with a dosing piston.
Compared to conventional systems, this makes it possible to add 30% more content to the capsule.
The resulting displacement of oxygen also results in better protection of the sensitive substances against oxidation processes.

Dosing system via vacuum
Dosing system via vacuum

We also have another dosing system for powders that cannot be compressed or for plant leaves, which sucks the material through a vacuum and then fills the capsules with the material.

The filling process is linked to the statistical weighing control, which regularly removes capsules during the manufacturing process and checks the weight to the milligram. If there is a risk of the filling weight deviating from the set weight, the control parameters are automatically adjusted (not possible with dosage by vacuum).

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This ensures that all capsules have the same filling weight and waste is kept to a minimum.

 

 

  

 



Capsule sizes

Capsule sizes: 1, 0, 00 (Vol­u­me: 0.50, 0.68, 0.91 ml)
Capsule sizes: 1, 0, 00 (Vol­u­me: 0.50, 0.68, 0.91 ml)

At present, the machine can manufacture capsules of sizes 1, 0 and 00.
Choice of capsules from vegetable sources or from gelatine.
 

 

Summary Encapsulation

  • Maximum capsule filling with powder compacting and dosing piston
  • Very accurate filling weight
  • Automatic adjustment
  • Statistical weighing control
  • GMP compliant
  • Capsule sizes: 1, 0, 00
  • Batch size from 50,000 capsules

 

 

 

 

 

 

 

 

Packaging

We can either provide bulk goods or package your products in blister packs or in plastic bottles.
 

Blister line

blister machine
blister machine

Our state-of-the art blister machine is in constant use and can process PVC/PVDC aluminium composite film, and where a maximum barrier is needed, also aluminium/aluminium foil. The production process complies with current GMP requirements, as the mechanical machine part is strictly separated from the product flow. Platen sealing at comparatively low temperatures ensures the protection of sensitive products. This procedure also provides particularly flat blisters. An integrated colour camera system continuously monitors the product flow and ensures that defective capsules or blisters are automatically rejected and removed.

 

Summary Blistering

  • PVC/PVDC-ALU and ALU-ALU blisters
  • Platen sealing at low temperatures
  • Control system with colour camera and pinhole detection
  • Up to 2 products in one blister pack
  • GMP compliant

 

 

 

 

 

 

 

Blister sizes

Bliste­r size 1 (97x60 mm) – PVC/Alu
Bliste­r size 1 (97x60 mm) – PVC/Alu
Bliste­r size 2 (130x82 mm) – Alu/Alu
Bliste­r size 2 (130x82 mm) – Alu/Alu

 

 

 

 

 

 

 

 

 

 

 

Tools for size 2:

  • 10 cavities for hard capsules size 0, 1 (coldforming blister)

Tools for size 1:

  • 10 cavities for hard capsules size 00, 0, 1
  • 8 cavities for hard capsules size 00
  • 10 cavities for soft capsules size 10 oval-shaped, 16 oblong, 20 oblong
  • 8 cavities for soft capsules size 20 oblong

Plastic bottle filling

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We use microcomputer controlled filling scales for the filling of hard and soft capsules, tablets and powders in plastic bottles of all types and sizes, with subsequent labelling and induction sealing.
This process technology meets all requirements under the food law.

 

Summary Plastic bottle filling

  • Plastic bottles in sizes from 75 ml to 1000 ml
  • Labelling with embossing of batch data
  • Induction sealing
  • Food law compliant

 

 

 

 

 

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Phone: +49 8102 80 650-0 • Fax: +49 8102 80 650-299 • Legal informationSitemap • All rights reserved.