Pharmaceutical Guidelines

Filter Validation in Sterile Manufacturing Filter validation is done in sterile pharmaceutical manufacturing to ensure that filter is working properly and sterilizing the material or air. An important aspect during the manufacture of drugs is sterile filtration. As simple as it may be to run to the nearest grocery store and grab any filters for your coffee maker, sterile pharmaceutical filters require validation to ensure the performance of the filter and quality of the end product. Typical objectives of a validation process include decreasing the risk towards the patient, ensuring sterility, reliable and reproducible results, and confirm viability for the market. According to a document found on the Parenteral Drug Association's (PDA) website, there are eight elements which constitute the process of sterile filtration validation: 1.Fit for Use: The filter meets requirements within product and process conditions. It is currently the industry best practice to validate and design  th...

Favourable Conditions for Microbial Growth in Cleanroom Area Microbial growth and contamination in sterile manufacturing area is a big issue. Microbial growth increases in sterile area due to the change in the environmental conditions. In the pharmaceutical industry, the end is to produce a drug that will help humanity in either promotion of health status, amelioration of the  disease condition or palliating a chronic illness. For this cause, the pharmaceutical companies provide for themselves a conducive place to make drugs. These special places have something in common; cleanliness and therefore called cleanroom   area. Cleanrooms are the most sterile places in drug production industry. Its function in keeping drugs as good as they should be is not to be overemphasized. But what happens if the so-called cleanroom is not sterile. What if they are contaminated by microbes? But then, what could even make microbes grow in such a sterile place. A lot of factors! You know tha...

Epoxy Flooring and Its Benefits in Pharmaceuticals Pharmaceuticals floor needs to be free from allergens and dust. Epoxy acts as a concrete floor sealant. They are safe and easy to clean, preventing microbial growth. The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor coating can be applied to concrete floors to ensure a high performance as well as an attractive surface. Epoxy consists of epoxy resins and hardening agents. These may sound like a bunch of scientific jargon thrown together but it is the secret behind industrial-grade durability of the floor. Epoxy resins also called polyepoxides are a polymer (a large molecule made of repeating sma...

Different Types of Hand Disinfectants Used in Pharmaceuticals Hand disinfectants are used to sanitize hand before working in pharmaceuticals therefore these must be effective to produce the best quality products. 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. Hand sanitizers are antiseptics used in conjunction with soap and water as part of an infection control program. The most common forms of disinfectants include gels, liquids, foams, mists and wipes. Hand Disinfectants and their Effectiveness There are currently three classifications of hand disinfectants available: these include alcohols, quaternary ammonium compounds and triclosan. Some disinfectant products contain ethanol. Ethano...

Different Types of Diffusers Used in Pharmaceutical Clean Rooms (Controlled Area) Know about different types of air diffusers used in HVAC systems in pharmaceuticals to disperse the clean air in cleanrooms. Air diffusers are used in clean rooms and other controlled areas to distribute the clean air passed through the HEPA filters.   Diffusers are the important part of the HVAC system and play a vital role in the maintenance of the classified area. The number of diffusers in a room depends upon the volume of the area, size of diffusers and required air changes per hour. Diffusers are mounted in the ceiling of the room to distribute the uniform air in the area and return risers should not be near the diffusers. Otherwise, air pockets will form that can increase the contamination   level in the area. Place and type of diffusers to be used should be included in the HVAC system qualification. Generally, three types of air diffusers are used in pharmaceutical industries. ...

Difference between Sterilization and Depyrogenation Sterilization and depyrogenation are useful process in sterile pharmaceutical manufacturing and both are almost similar but have huge difference. To understand the difference between sterilization and depyrogenation, we have to discuss both of them separately, in length to really know the line that separates them. Basically, sterilization is a method that can remove, kill and deactivate microorganisms on a surface like for example the s tainless equipment , media etc. On the other hand, due to the high variability of their molecular weight, pyrogens are hard to sterilize. Depyrogenation refers to removing pyrogen from a solution or pharmaceutical vials. Endotoxins are bacterial byproducts that become pyrogenic (active) when released into the bloodstream. As you are perfectly aware, eating food or injecting drugs that contain microbes will cause infections. Sterilization is used in the food manufacturing and pharmaceutical industrie...

Difference between Sterile and Pyrogen Free Depyrognation and sterilization are different concepts. All sterile things are not pyrogen free. Pyrogens are endoroxins those require high temperature to denature. Introduction It is often believed that being sterile means being pyrogen-free but this is not correct. First of all, you need to understand what pyrogen is. Pyrogen is any substance that causes fever in animals and humans when it gets into their body. A very common symptom of fever is increasing in temperature so pyrogen is sometimes seen as any substance that causes an increase in temperature in humans and animals. Endotoxins are very common pyrogens and they are contained in the outer membrane of the cell of some Gram-negative bacteria. When these bacteria are killed by the immune system of their hosts (usually animals and humans), antibiotics or sterilization, they release dangerous endotoxins during their cell lysis. That being said, you should easily understand the differ...

Difference between Injection and Infusion Injections and infusions both are sterile products but they have great difference in their administration to the human body. These differences are discussed in this articles. Both injection and infusion are medical terminologies. They are both ways of a dministerin g medicine to a patient and important in health and life- saving. The medicine is usually in liquid form. Many people are usually confused and do not know their differences. There are various differences between injection and infusion. These include: Injection in most case is known to be a 'shot' using a needle or a syringe. It usually takes a short period of time while an infusion takes quite a lot of time (more than fifteen minutes), probably for about thirty minutes or even longer. It is a slow method of medication to a patient. An injection is administered within muscles (intramuscular), or intra-aerial, or beneath the skin (intradermal) or within the fat or the skin o...

Difference between Fumigation and Fogging Fumigation and fogging are very important processes in cleanroom area to minimize and control the microbial load. 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. It is very important to know both the processes to thoroughly understand the differences. In fumigation, formaldehyde solution is mixed with the potassium permanganate in a fixed proportion. This mixing of formaldehyde with potassium permanganate gives rise to fumes, which are very effective in killing bacteria, fungus, and their spores. This is one of the most preferred ways of controlling the contamination. While fumigation involves spraying form...

Difference Between Aseptic and Sterile Conditions Aseptic and sterile conditions are different from each other because one should free form pathogens and other should free from microbes. read the articles for details. The difference between "aseptic" and "sterile" is not always properly understood. These terms, which can be obviously used in a medical setting, also apply to the safekeeping of food and other perishable goods that can be attacked by bacteria, fungi or viruses. In a pharmaceutical context, it is very important to know which is which and what they represent medically. They sound similar but cannot be mixed up or will put a sensible product at risk. Aseptic and sterile go hand in hand. The common point between the two terms is that they are both techniques that strive to get rid of microscopic organisms that can be harmful and risk the safety of an environment, a liquid, a wound or a tool among other things. To truly get the specific characteristics of t...

Design of a Sterile Facility in Pharmaceuticals Learn how to design the sterile facility in pharmaceuticals including walls, floors, ceilings, doors, drains and lightings. Efficiency and the maintenance of the sterile area directly depend upon the design of the sterile facility. Good design can save the area maintenance cost and quality of the area. Following things should be considered while constructing the clean rooms. Walls: Walls of the facility should be constructed of a smooth material, steel or e poxy coated materials may be used. All exposed area should be smooth to avoid the shedding of particles and the microorganisms. Floors: Floors should not have pores, non-slippery, non-absorbing, resistant to disinfectants and should be cleaned easily. Generally, 3.5 mm thick epoxy is used on the floor in pharmaceuticals. Corners on the floor should be covered with coving to prevent the accumulation of dust. The floor should be hard enough to bear the heavy loads of equipment and ...

Depyrogenation in Injection Manufacturing Learn how to remove the pyrogen from vials and analysis accessories in pharmaceuticals. Depyrogenation is the removal of pyrogen (endotoxins) from the pharmaceutical materials or equipment. Endotoxins are the lipopolysaccharides found in the cell walls of the gram-negative bacteria. Pyrogen causes fever when entering the bloodstream. Endotoxin is measured in Endotoxin Units (EU). Endotoxin in w ater for in j ection (WFI) should not be more than 0.25 EU/ml. There are following methods for depyrogenation in pharmaceuticals. In Quality Control: All instruments used in the analysis for endotoxin should be depyrogenated to get accurate results. Test tubes and other accessories are depyrogenated by heating in d r y heat sterilizer (DHS) at 300ºC. In Manufacturing: In sterile product manufacturing vials are depyrogenated by dry heat at 300ºC using d epyrogenating tunnel . A combination of the temperature of chamber and belt speed is used ...