When pharmaceutical specialists speak about way of manufacturing effectiveness, they usually emphasize machinery, machinery automation or improvement of production methods. But in practice, many reasons of delays in production, quality non-compliance and sudden stoppage are connected with utility systems that is not taken seriously enough.
Showing posts with label Equipment. Show all posts
Recovery Factor Studies in Cleaning Validation: A Practical Guide
Cleaning validation plays a vital role in manufacturing as it ensures that all manufacturing equipment is being cleaned according to the set cleaning limits. Cleaning validation depends on how reliable the chosen analytical method would be as well as how effective the sampling technique used is at getting the residues from the surface of the equipment.
Cleaning Validation Failures and Their Root Causes in Pharmaceuticals
Validation of cleaning processes is an essential function in the pharmaceutical industry by providing documented proof that manufacturing equipment can be cleaned consistently to acceptable limits. Properly validating cleaning processes helps to avoid problems like contaminating one product with another product, carrying over active ingredients, having microbes on in-process materials, detergent …
Energy Saving Strategies in Pharmaceutical Manufacturing Plants
Energy usage is one of the biggest business costs in pharmaceutical manufacturing facilities. Modern pharmaceutical factories have complex facilities that include HVAC systems, purified water, compressed air, cleanrooms, production equipment, cooling and an automated manufacturing line, all of which require large quantities of electricity, gas and fuel.
Fire Safety in Pharmaceutical Plants | GMP and Risk Control
Fire safety plays an important role within pharmaceutical manufacturing as many hazards are associated with fires and explosions from solvents, chemicals, dust created during processing, electrical equipment, utility systems and/or high temperatures generated through machinery in order to produce the products. If a fire were to occur in a pharmaceutical facility all of the following could happen:…
Principle and Working of Autoclave in Pharmaceuticals
Sterilization is an essential operation in pharmaceutical manufacturing, particularly when it comes to sterile products. Impacting directly upon patient safety, contamination control is of utmost importance at sterile product facilities. Within the entire spectrum of methods used to sterilize materials for use in the pharmaceutical industry, autoclaving (steam sterilization) is presently accepted…
Cleaning Validation Challenges in Oral Solid Dosage Manufacturing
Cleaning validation is one of the most critical components of pharmaceutical production due to its role in ensuring that all equipment used in manufacturing processes is cleaned according to predetermined criteria. In OSDs, the multiple-product use of equipment makes cleaning validation even more crucial than other forms of pharmaceutical manufacturing since improper cleaning can result in cross-…
Temperature Sensors in Pharmaceuticals | Types, Working and Features
All aspects of the manufacturing, storage and distribution processes of pharmaceuticals are affected very greatly by temperature. Any deviation in temperature can negatively affect the quality, potency and safety of the product. Temperature sensors are extensively used in clean rooms, warehouse and cold chain environments as well as manufacturing equipment to help make sure that the temperature i…
Site Acceptance Test (SAT) in Pharmaceuticals
The qualification of equipment in the manufacturing of pharmaceuticals is an organized approach to confirm that the systems perform as expected. When equipment passes the Factory Acceptance Testing (FAT) at the vendor's location, it is tested again when installed at the manufacturing site. This testing is referred as the Site Acceptance Testing (SAT).
Factory Acceptance Test (FAT) in Pharmaceuticals
In the pharmaceutical industry, the equipment and automated systems must be tested for reliability before being installed into a manufacturing facility. One of the most common methods of testing for reliability is through a Factory Acceptance Test (FAT). The FAT is a critical test for validating equipment and automated systems to ensure that the performance, compliance and quality of equipment is…
Principle and Working of Gas Chromatography | GC Principle Explained
Gas chromatography is one of the most useful analytical tools in pharmaceutical and chemical laboratories. Because of its reliability and accuracy, this technique has been used for decades to analyze chemical and pharmaceutical products.
Equipment Failure in Pharmaceutical Manufacturing
Pharmaceutical industry has great expectations and opportunities because medicines play an important role in everyone’s life. The pharmaceutical manufacturing process is complex and time taking. A lot of equipments are required to manufacture a batch of drug products.
Determination of Hot and Cold Spot in Stability Chamber
Everything from pharmaceutical products to personal consumer products is tested in stability chambers to get an accurate reading of conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.
Qualification Procedure for Vial Washing Machine
Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
Alarm Challenge Test in Pharmaceuticals
The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and…
