Weleda Tests Anthroposophic Medicine in Line with ICH Guidelines

Weleda tests anthroposophic medicine in line with ICH guidelines

The work of the holistic natural cosmetics Weleda even has its own biodynamic hor- Requirements and anthroposophic medicine manufactu- ticulture and tincture production facilities .  Stability testing in line with ICH rer Weleda is based on the spiritual philo- guidelines for medicine sophy of Rudolf Steiner and aims to unite Medicine testing in line  Testing for stability after opening humankind and nature in perfect harmony. with ICH guidelines  Accelerated aging process The company was founded in 1921 in Weleda's Quality Control Analysis Service Arlesheim (Switzerland), with two further handles not only analytical and microbio-  Controlled microbiological infestation hubs added in Huningue, (France) and logical release testing and methodology  Constant climatic conditions Schwäbisch Gmünd (Germany) over the development, but also medicinal stability  Cyclical temperature and humidity years. These three sites are where the studies in line with ICH guidelines values majority of the around 1,000 natural raw (International Conference on Harmonisa- materials are turned into 120 natural cos- tion) in a GMP-compliant (Good Manufac- BINDER solutions metic products and several thousand turing Practice) environment. The ICH medicines. These products are manufac- guidelines stem from the European  Climatic conditions compliant tured on a purely natural basis without any Union's GMP (EU-GMP). The purpose of with ICH guidelines artificial preservatives, and to this end, standardizing technical standards across  KBF 720 constant climate chamber  MKF 240 dynamic climate chamber  BD and KB incubators  Variable temperature and humidity settings  Homogeneous temperature distribution inside the chamber  Fast recovery time  Incubation with cooling function

 Jochen Grimm, Weleda Qualification Team Leader for Schwäbisch Gmünd, Germany

the pharmaceuticals industry is to ensure that medicines can be clearly recognized by the respective regulatory authorities in Europe, Japan, and the USA. Weleda has been using BINDER's KBF 720 constant climate chambers and MKF 240 dynamic climate chambers for years to carry out these studies, not to mention several incubators from the BD and KB series. “We have been working with BINDER units for years now and have total confidence in the high levels of reliability, service and support that go hand in hand with the chambers,” explains Jochen  Medicine stability test in a KMF constant climate chamber Grimm, Qualification Team Leader re- sponsible for manufacturing, validating, stant climate chamber with constant con- humidity settings presents a real ad- and qualifying cooling and air conditioning ditions of 25 °C / 40 % RH; 25 °C / 60 % vantage. “The chambers maintain the set units. The medicines are subject to strin- RH; 30 °C / 65 % RH; or 40 °C / 75 % RH values with the utmost precision. Not only gent safety precautions and are therefore for a period of 6 to 120 months. The inves- that, but the temperature and humidity are also tested in accordance with the Euro- tigation cycles are also performed in line distributed homogeneously throughout the pean Pharmacopoeia (Ph. Eur.), the Ger- with the specifications listed in the ICH inner chamber.” man Homeopathic Pharmacopoeia guidelines. Tests for stability after opening (HAB), or the German Pharmacopoeia – also known as “in-use” tests – are orien- Unmatched safety (DAB) depending on requirements. ted toward the use of compounds and aim Medicines are subject to stringent safety to establish their shelf-life in relation to their standards, yet in spite of these precau- “We have been working with actual conditions of use. tions, the specimens still have to undergo BINDER units for years now regular checks for germs. To this end, Accelerated aging process BINDER laboratory staff use BD incubators and have total confidence In addition to the stability test, laboratory and KB cooling incubators. In the high levels of reliability, staff also perform long-term simulations service and support that with dynamic climatic conditions in a At the heart of every interaction between come with the chambers.” MKF 240 dynamic climate chamber. The Weleda and its partners, suppliers, and specimens are exposed to extreme clima- employees lies its underlying ambition to Jochen Grimm, tic conditions under cyclical temperature unite humankind, the company, and nature Qualification Team Leader and humidity values to accelerate the in perfect harmony. The company has aging process and allow staff to investigate upheld this philosophy for over 90 years In accordance with ICH guidelines and the behavior of the products in cases of and never faltered from its renowned qua- depending on the specified climate zone, heavy exposure. Jochen Grimm believes lity standard. the compounds remain in a BINDER con- that the ability to vary the temperature and

Advantages Contact data:  Extended temperature range Weleda AG from -10 °C to 100 °C Möhlerstraße 3  Large climate range of up to 90 % RH D-73525 Schwäbisch Gmünd www.weleda.com  Automatic water and waste water

management Contact person:  Precise climate conditions Jochen Grimm  Fast and precise humidification Qualification Team Leader Quality Control Analysis Service Areas of application (QK-AS)  Pharmacy  Automotive

 Packaging  KBF 720 constant climate chamber

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