Blow-Fill-Seal (BFS) technology is a manufacturing technique used to produce small, (0.1mL) and large volume, (>500mL) liquid-filled containers.Originally developed in Europe in the 1930s, it was introduced in the United States in the 1960s, but over the last 20 years it has become more prevalent within the pharmaceutical industry and is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.
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.
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.