We use our knowledge and our commitment in the laboratory for the development of new products.

Annette Lettow

 icon_labor  Research & development


All new products are developed and tested at our own laboratory. Medical devices or cosmetics products, whether natural or conventional – we supply everything from a single source.

One of our particular strengths is the consideration of customer-specific requests and current market trends.


 icon_labor  Quality assurance


Numerous tests and quality controls ensure sound production processes of consistently high quality.

Partner laboratories

Test logos

Our services in quality assurance

R

Stability testing

R

Dermatological testing

R

Microbiology

R

GMP – good manufacturing practice

R

Processing test

R

Documentation


 icon_labor Regulatory Affairs


Safe products also include correct declaration, documentation and registration. We provide all services directly – qualified, fair and without a lot of red tape.


Technical documentation (medical devices)

We create the technical documentation for you as well as the corresponding necessary registrations and tests for safe medical devices. The technical documentation shows the compliance with the applicable basic requirements of the Medical Devices Directive 93/42/EEC, Annex I, in each case and confirms this with a declaration of conformity.

CPNP (cosmetics)
Cosmetic products which are placed on the market in the EU have to be notified before they are placed on the market. This is stipulated by article 13 of the EC Cosmetics Regulation 1223/2009. We support you with the registration of your company and with the notification of your cosmetic product on the  Cosmetic Products Notification Portal (CPNP).
Product information file (cosmetics)
We create the required product information file (PIF) according to article 11 of the EC Cosmetics Regulation. This file includes the description of the cosmetic product, the manufacturing methods and the safety report including the safety assessment. You can act as the responsible person according to article 4 EC Cosmetics Regulation.
Marketability

We supply you with all required information for creating your print data. This primarily includes the required information such as ingredients and intended use. Additionally, we also verify the voluntary information and claims of the cosmetic product taking into account the legal requirements. Some initial advice can be found  here.

DIN ISO 9001 and EN ISO 13485

As a manufacturer of cosmetic products and medical devices, we are certified to EN ISO 9001 and EN ISO 13485. An essential principle of EN ISO 9001 is process orientation. The international standard EN ISO 13485 is the standard for quality management systems in the field of medical devices. In addition to the positive quality effects, the certification is often also a prerequisite for exporting our products.

Your contact for regulatory affairs and quality management

Sabine Vollmer

Sabine Vollmer

Tel.: +49 (0)2824 2083-27
sabine.vollmer@bb-kalkar.de


We work with state-of-the-art technology at our new production facility, built in 2014.

Carsten Weyers

icon_herstellung  Production

In addition to formulations developed by us, it is also possible to produce customer formulations at beinio®.

After registration in the integrated materials management system, production is carried out in line with strict GMP regulations. Compliance with the quality management system ensures perfect product quality. Process mixing plants from 15 – 2,000 kg cover a broad range of production lot sizes.

PRODUCT RANGE

  • Fatty ointments
  • W/O emulsions
  • O/W emulsions
  • Gels
  • Surfactants
  • Liquids

Flexibility and consistently high quality: That is what sets us apart from others, that is what you can rely on.

Norbert Reiche

icon_tube  Filling technology

A broad range of modern filling systems forms the basis of our powerful and flexible production facilities.

Whether full service or contract filling – we are the right choice if you are looking for a reliable partner.

FILLING TECHNOLOGY

  • Cans/jars
  • Tubes
  • Bottles
  • Sachets/product samples
  • Wet tissues (single pack)
  • Tubular bags

You can count on experience and sound technology. We make things colourful!

Christopher White

icon_druck  Printing & packaging

At our own flexo print shop we print films at the highest quality level. Screen printing and embossing as well as high frequency bonding for plastic film complete the area of film finishing.

We work with reliable and innovative partners to ensure maximum individualisation and creativity for primary and secondary packaging as well as for design.

FILM FINISHING

  • Flexo printing
  • Screen printing
  • Embossing
  • High frequency bonding

Our packaging types at a glance

Sachets

Fill level: ­
2 ml – 30 ml

Format: ­
60×80 – 80×170 mm

Minimum quantity:
from 20.000 units

Tubes

Fill level: ­
5 ml – 300 ml

Format: ­
19×60 – 50×200 mm

Minimum quantity: ­
from 5.000  units

Pots

Fill level: ­
30 ml – 500 ml

 

Model:
individual

Minimum quantity:
from 5.000 units

Bottles

Fill level: ­
10 ml – 1.000 ml

Model:
individual

Minimum quantity: ­
from 5.000 units