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The new version of GMP puts forward specific requirements for cleaning validation and risk control, emphasizing that all parts in contact with drugs must use “repeatable” and “recordable” cleaning methods to remove residues in the production process, aiming...

1 Overview Of Sterilization Of Sterile Drugs   Sterilization method refers to the method of killing or removing all surviving microbial propagules or spores by physical and chemical methods to make the sterilized items sterile. In the production of sterile drugs, the prevention...

What Is A Bottle Unscrambler?   A bottle unscrambler is an equipment used in the bottling industry to feed bottles into manufacturing lines. There are several designs available, but their objective is the same: to feed bottles mechanically at fast rates, removing the costly and...

Self-inspection methods can be divided into three types: data inspection, face-to-face communication and on-site inspection. This paper explains the necessity of self-inspection for drug manufacturers, introduces the feasibility and function of self-inspection, and provides specific...

Eight of the top 10 blockbuster products in global annual sales are therapeutic biological drugs. As the production site of biological products, the clean workshop of biological products should not only meet the special process requirements of biological products, but also consider...

What Exactly Is Material Engineering?   Material engineering is a branch of science that studies the attributes of substances in order to generate new materials with improved chemical and physical properties. Engineers in this discipline are also active in the optimisation of...

Solid dispersion is one of the important strategies to improve the oral bioavailability of poorly soluble drugs. At present, more than ten oral preparations of poorly soluble drugs based on solid dispersions have been approved worldwide. In solid dispersions, drugs are mostly uniformly...

Part 1 Drainage System Of Clean Room (Area)   The drainage system of the clean room (area) referred to in this article refers to the indoor drainage system.   The task of the indoor drainage system is to quickly discharge the sewage from washing and sanitary appliances and...

Lactose has been used as a pharmaceutical excipient in the 1960s for more than 60 years. Now lactose has become a common basic excipient in solid preparations, and it occupies the forefront in the proportion of prescriptions. Lactose can occupy such an important position in preparation...

In the freeze-drying process, the eutectic point and eutectic point of the material are the two most important parameters in the freeze-drying process. The pre-freezing temperature of the material should be 5-10°C lower than the eutectic point of the material. Ensure that the material...