Even the simplest form of pharmaceutical manufacturing process can involve a range of process steps before the product is packaged and shipped to the consumer.These may include:
Poor environmental control, particularly in terms of air humidity can directly affect the pharmaceutical production line in a number of ways. Levels of humidity below 45%RH will allow electrostatic charges to build up in machinery and materials.
There are many factors to be considered in the quest for drug quality assurance.These include environmental moisture, stability and packaging solutions.If all of these aspects are addressed throughout the manufacturing and storage processes, the product can be isolated and protected from all possible threats to quality and efficacy.
Validation is establishing documented evidence which provides a high degree of assurances that a specific process or equipment will consistently produce a product or result meeting its predetermined specifications and quality attributes.This article focuses on the process of dry mixing of powders, as one of the steps in producing tablets.Validation can therefore be applied to the dry mixing process itself, as well as the overall manufacture of tablets.
Powders and granules can be used as dosage forms in their own right, but by far the greatest use of granules and powders in the pharmaceutical industry is as an intermediate during the manufacture of compressed tablets.
There are several ways to prevent cross contamination during production and below are some ways to do so. Before starting, line clearance should be performed as per the SOP of the company. Do a checklist and record. Check to see if any starting materials are missing, previous record documents, product residues and product itself. Practice a closed system when handling the materials.
In this short article we state the guidelines to follow during the online and offline packing for pharmaceutical companies.
Hygrometers are important devices in the pharmaceutical world as it measures the relative humidity of the atmosphere, which can affect the products during the manufacturing process. The device includes two thermometer – the dry and the wet bulb. The dry bulb remains dry while a cotton wick that is dipped in water surrounds the wet bulb. In the measurement of humidity, the wet bulb plays an important role.