There are different types of hand disinfectants used in pharmaceuticals. These differences can be attributed to the fact that each one varies in its mode of action and the level of activity. It is important to utilize different types of sanitizers in pharmaceuticals because the mode of action in each is needed to prevent the resistance of microbes.
Top 10 Tips for Microbial Limit Test
The microbial limit test is the quantitative and qualitative assessment of the microbes or microbial contamination test in a sample. This test is performed for:- estimation of the total viable count of fungi and bacteria i.e. Quantitative estimation. Identification of each of the microbes of importance by culturing on selective media i.e. Qualitative estimation.
Requirements of FDA for Training in Pharmaceuticals
The FDA compels every drug or medical devices manufacturer to train every employee starting with the regulated procedures to the CFR requirements. The FDA GMP training requirements in pharmaceuticals are defined in 21 CFR 211.25 and have three key aspects.
Importance of Data Integrity in Pharmaceuticals
These days, pharmaceuticals have started relying on computers and automated systems to a great extent, whether in terms of manufacturing, laboratory release testing or many other tasks involved. Due to this, a renewed focus has been brought to the concept of data integrity. It is the responsibility of the pharmaceutical industry to ensure the efficacy, quality and safety of drugs, and at the same…
Requirements for Good Documentation Practice (GDP)
Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of documents.
Difference between Fumigation and Fogging
To keep the controlled area from being contaminated in pharmaceuticals, two processes namely fumigation and fogging are used. Both the processes are used for the same purpose, but the difference between fumigation and fogging in pharmaceuticals is great. Moreover, fumigation is banned in few pharmaceuticals because of its negative effects while fogging is a safer option than the former.
Environmental Risk from Microbial Waste
Microbial waste includes any product that emanates from or has been used in tampering with microbes. This includes discarded cultures of microorganisms and infectious agents i.e. bacilli, discarded microbial specimens from pharmaceutical laboratories, pathological or research institutes, live and attenuated vaccines that have been discarded are also considered as waste and lastly, disposable Pet…
Periodic Review and Compliance in the Pharmaceutical Industry
Compliance in the pharmaceuticals is key to success, not only because it is required by law, but because the pharmaceuticals industry is considered one that doesn't allow mistakes. That is, if you make a faulty cell phone, your customers will ultimately get angry at you, but nobody gets hurt. With pharmaceuticals, any kind of error in the production can cause from nothing to death, and it is …
Self Inspection and Its Implementation in Pharmaceuticals
Self inspection is basically a very useful and powerful mechanism for detecting any shortcomings or faults operating within any system. It means one needs to redeem on their own policies and check for its conformity and compliance with the appropriate corrective measures. It is a sure-shot way to evaluate the whole operating system from every aspect to ensure and maintain the quality of products.…
Basics of Cleaning Validation
Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.
Types of HVAC Systems
Jul 13, 2020
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Introduction
HVAC is a short form of Heating, Ventilation, and Air Conditioning. It is a system with the main purpose of making indoor surrounding more comfortable. HVAC systems are available in different types which come with unique specifications in order to suit your environment.
Types of HVAC systems There are basically four types of HVAC systems. They include:
Heating and Air Conditioning S…
Types of HVAC systems There are basically four types of HVAC systems. They include:
Heating and Air Conditioning S…
CAPA and Its Proper Implementation
When we are sick, we always trust the medical product believing that they will certainly provide relief. We get assured that the medical care we receive is not faulty. It is so fortunate that failure is not frequently experienced in medical devices and healthcare. Oftenly failure can occur, and the investigation is carried out to explain the reasons why it occurred.
Sanitation of Cleanroom Area in Pharmaceutical Manufacturing
It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. The area should be clean after a defined period as per standard operating procedure.
Computer System Validation in Pharmaceuticals
Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity. Computer system validation also reduces long-term system and project costs by minimizing the cost of maintenance and rework.
GMP for Sterile Pharmaceutical Manufacturing
Maintenance of sterile area is a critical task because of air, as well as the personnel working in the sterile classified area, are the main source of the contamination. Following are some good manufacturing practice points those shall help in the maintenance of sterile area.
