Microbial acceptance criteria for cleaning validation are used to show that the cleaning process provides the required level of control over microbial contamination for the intended use of the equipment. A single universal microbial limit is not a valid approach to all pharmaceutical cleaning validation studies. The microbial limits should be scientifically justified based on product, process, eq…
Showing posts with label Microbiology. Show all posts
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…
Validation of Biological Indicators for Sterilization
One of the most important processes in the manufacture of pharmaceuticals is sterilization, especially for products intended to be sterile. The success of this sterilization will have a direct impact on the safety, quality and ultimately health of the product(s) being manufactured. The use of Biological Indicators (BIs) is a preferred method for the pharmaceutical industry to verify that they are…
Disinfectant Validation in Pharmaceuticals | Complete GMP Guide
In manufacturing pharmaceuticals, controlling contamination is vital in clean rooms and sterile areas. To do this, we rely heavily on HEPA filters as well as heating, ventilation and air conditioning (HVAC) systems to keep air quality high; however, surface contamination is still a threat to us. It is in this scenario where disinfectants become very important.
HEPA Filters in Pharmaceuticals | Working and Applications
Clean air is primary fundamentals for a pharmaceutical factory. Airborne residue and micro-organisms can influence quality and patient’s health. HEPA filters are most common used in the pharmaceutical factories as an effort to achieve minimal contamination in controlled environments.
Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas
The pharmaceutical industry holds its sterile drug products, including injectables, of the highest degree of cleanliness and prevention from contamination. A number of sterile drugs do not have an option for being subjected to terminal sterilization. Because of this, the process for producing these sterile products through aseptic processing has great importance.
Best Practices for Isolator Technology in Pharmaceutical Manufacturing
Ensuring that sterile and contamination free environments are maintained has become even more critical for manufacturers of sterile pharmaceuticals today due to the need to control the potential for cross contamination in drug manufacturing which is particularly important when dealing with the production of sterile drug products, Biologics and High-potency compounds. One of the primary technologi…
The Rotation of Disinfectants Principle - True or False
This is something many quality professionals debate about, so not everyone feels the same way about how important disinfectant rotation can be. There are some quality professionals who believe that using different disinfectants at different times will make it less likely that microorganisms will become resistant to the disinfectant and therefore continue to provide effective cleaning and sanitiza…
Common Microbiology Concerns in FDA Inspections
Microbiology plays an important role in FDA inspections, whether it is in sterile manufacturing or non-sterile manufacturing because problems with microbial control systems will affect product quality and patient safety.
Validation of Shelf Life for 70% v/v Isopropyl Alcohol
Isopropyl alcohol 70% is one of the most commonly used disinfectants and the pharmaceutical industry. It is used for surface disinfection, equipment sanitization, hand decontamination in cleanrooms and aseptic processing areas.
Environmental Monitoring Trending | Alert/Action Levels
In sterile product manufacturing where microbial contamination directly impacts product quality and patient safety environmental monitoring is one of the most critical components. Regulatory agencies like USFDA, EMA, WHO and PIC/S require clearly defined alert and action levels of environmental monitoring. Simply defined limits are not enough for environmental monitoring but manufacturers must ap…
Autoclave Validation in Pharmaceuticals
In pharmaceutical manufacturing facilities, sterilization is one of the most critical processes. Any error in sterility testing can compromise product quality and patient safety. From all sterilization techniques, moist heat sterilization is commonly used method for pharmaceutical articles because of its reliability, efficiency and cost effectiveness.
HVAC System Validation in Pharmaceuticals
In pharmaceutical manufacturing, HVAC system plays an important role in maintaining controlled environmental conditions that are necessary for product safety and regulatory compliance. Validation of accuracy system ensures that it performs according to design specification and meets regulatory requirements.
Top 4 Problems in Sterile Pharmaceutical Manufacturing
Sterile pharmaceutical manufacturing is the most demanding area in pharmaceutical industry. Injectable drug products and other formulations are produced in sterile area. These products must be free from microbial contamination, pyrogens and particulate matter. Any contamination in these products and life threatening because they are administered directly into the stream.
How to Strengthen Microbiological Control of Non-Sterile Pharmaceuticals
Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products are manufactured in a sterile environment, but non-sterile products like tablets, capsules and liquid pharmaceutical products are manufactured in non-sterile manufacturing area.
