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.
The buffer area is the space or area in the manufacturing facility where sterility of the area is strictly implemented. A compounding area in a pharmaceutical facility is known as the buffer area and is classified as ISO 7 area or class 10,000 with excellent air quality.
The principles of GMP are a follows, the structure, device and equipment should be designed, installed, placed, operated and maintained as per its intended use and purpose. Integral system whose consistency in performance and having an impact to product quality should be validated whenever appropriate such as the air handling system, water purification, compressed air system and stem system.
A Mix–Up may be defined as:
- An unplanned combination of various compounds.
- A mistake brought about wrongly identifying one material for another.
A mix-up can be caused by bad judgement or lack of attention to detail, i.e., human error. It can also occur though poor communication between personnel.
First discovered in 1928 by Alexander Fleming, penicillin is now one of the most common drug used to help cure patients from bacterial infections. The beta lactam ring of the penicillin is the one responsible for the drug’s anti-microbial activity, which many of the antibiotics medicine have.
The packing process is an integral part of the manufacturing process for pharmaceutical products. Below is a summary of good practices that may help streamline the packing process.
The following is a brief operating and cleaning guide that can be used for most tablet de-dusting machines. It covers pre-start up, operation and cleaning, and lists some precautions that can be taken to help avoid contamination issues.