From witchcraft to modern pharmaceutical industry
Many industries make a number of specific demands to control and monitoring equipment. For example, these include dust and moisture proofing and explosion protection. In the pharmaceutical industry, the equipment shall comply with GMP Directives. For this industry, Pepperl+Fuchs offers ready-made solutions, which are described in this article.
Practices and benefits of implementing GAMP
High-quality imported pharmaceuticals have become less affordable for people due to the economic crisis. To improve the situation, the government extensively supports import substitution projects, including those within the framework of the "Pharma 2020" program .The green light has been given, but most domestic pharmaceutical enterprises are now facing a serious problem: their production facilities do not comply with international quality standards (GAMP). This, in turn, deters foreign investors and customers. Readers will also learn about the successful experience in automation in accordance with the GAMP 5 standard.
Upgrade and validation tests of hardware-software complex of ethylene oxide sterilizer
The article focuses on the upgrade and preparation for validation testing of an automated control system of the ethylene oxide sterilizer manufactured by the Production Association DELRUS CJSC. Also discussed are solutions to problems occurring during the upgrade of the system and subsequent validation tests.
Implementation of the redundant data acquisition and archiving systems at the industrial facilities
The redundant data acquisition and archiving system allows pharmaceutical companies to have a highly reliable system for tracking parameters in accordance with the GMP requirements. When necessary, the system is able to provide the interested persons with the documents confirming the compliance with the requirements of the technological processes and microclimate of the clean rooms.
Autonomous Systole Rhythm Register
The autonomous device for functional diagnostics is described. It is intended for twenty-four hours registration of human systole rhythm. Registered rhythmogram is being transmitted into the personal computer for the visualization and mathematical processing.