New equipment: industrial oven and drums mixer
Starting from the month of January 2017 we installed in our warehouse two industrial ovens with a capacity of 16 x 200 l drums or 4 x 1000 l IBCs designed for the heating of products which are in a crystalline state at ambient temperature or which have such a high viscosity that they can not otherwise be easily managed.
Heating of the materials up to 100°C is achieved by convection through the use of fans for continuous recirculation of the air inside the oven, or by natural convection without fans.
Moreover, a drums mixer has been installed with the purpose to blend and homogenise various bulk materials such pharmaceutical and chemical products in drums up to 200 l / 450 kg.
LABORATORY GLASSWARE WASHER WITH DRYING SYSTEM
Starting from March 2017 we installed in our facility a laboratory glassware washer with drying system.
This machine allows a washing up to 95°C and antibacterial thermal disinfection, it is provided of a microprocessor and a programmable electronic control. The final rinsing is performed with demineralized water and the drying phase can be programmed based on the needs and on type of the materials to be washed.
Through a serial port RS232 the machine can be connected to a printer or a PC and the registration of each cycle can be downloaded.
The efficacy of the disinfection cycle can be evaluated through the evaluation of the temperature graph and the calculation of the A0 parameter for thermal disinfection according to EN ISO 15883-1.
This machine is indicated for washing non-sterile sampling tools and containers such as glass or plastic bottles intended for dispensing of API in our cleanroom.
For more information contact us!
EU GDP Guidelines now official in Switzerland
On 8 September 2013 the Guidelines on Good Distribution Practice of medicinal products for human use became effective in the EU Member States.
It was unclear for a long time what validity these Guidelines have in Switzerland, as a non-EU state. Within the framework of the agreement between the Swiss Confederation and the European Community on Mutual Recognition Agreements (MRA) Switzerland has committed to respect European principles of law as far as they include GMP regulations. Thus, the GMP regulations of the relevant directives such as 2001/83/EC also apply.
For the EU-GDP Guidelines, the Swiss Federal Office of Public Health (Bundesamt für Gesundheit, BAG) recommended that in particular internationally active companies with corresponding Swissmedic approval should already implement the new GDP Guidelines as far as the current applicable GDP Guidelines defined in Annex 2 of the AMBV are still met.
Now the Federal Department of the Interior has implemented the EU-GDP Guidelines, through the adaptation of Annex 2 of the Medicinal Products Approval Regulation (AMBV). The adjustments became effective on July 1, 2015 - with a planned implementation period of six months.
The implementation as well as the definition of possibly needed technical directives is now up to the SwissMedic.
Ordinance for authorisation of medicinal products, update of 10 Jun 2015