Pharmaceutical manufacturing has aseptic production as one of its toughest processes because the end product has to stay sterile without the need of terminal sterilization after filling. This implies that the process must include control of microorganisms and the contamination due to particles at every manufacturing step, starting with the preparation of the components, through the actual filling…
Showing posts with label HVAC. Show all posts
Smoke Study Mistakes and Solutions in Pharmaceutical Cleanrooms
One of the most essential qualifications performed within sterile pharmaceutical manufacturing facilities is the execution of smoke studies (airflow visualization studies). These prove by visual verification that the airflow produced protects the sterile products during manufacturing, filling and during any aseptic activity.
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.
Sterile Area Cleanroom Qualification in Pharmaceuticals | Complete Guide
One of the strictest levels of environmental control is needed to produce sterile pharmaceuticals in a manufacturing facility. The following types of products need to be made in an area where there is limited risk of contamination: injection drugs, medications intended for the eyes and sterile powder products. If any product has even a very small amount of particles or bacteria in it, it can affe…
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.
GMP and Room Design in Pharmaceuticals | Key Principles Guide
Quality assurance is dependent upon the design of production spaces; therefore, not only is the infrastructure of a facility important, but also the specific design of each production space. For example, the layout of the room, the types of materials used in constructing the room, the way air flows into and throughout the room(s) and each room’s environmental controls directly affect the quality …
Essential Steps for Setting Up a Pharmaceutical Cleanroom
One of the most difficult and critical areas in designing a pharmaceutical facility is establishing the clean room. The clean room is not merely a controlled area but rather a specifically engineered environment to reduce the chance of contamination and ensure that all of the environmental conditions like air quality, humidity, temperature and pressure within it are maintained consistently.
Basics of HVAC System | Components and Working
Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Maintenance of area and air quality by filtration and temperature and humidity is controlled by using an HVAC system.
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.
Air Handling Unit and Its Working Process
Air handling in pharmaceutical manufacturing is important to maintain the safety and quality of the products. In this article, we shall understand the working of air handling units in pharmaceuticals to produce safe and effective products.
Requirements and Maintenance of HVAC System in Manufacturing Facilities
Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental conditions in the manufacturing area. Therefore, environmental conditions of the manufactur…
Duct Designing in HVAC System
Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.
Difference Between HEPA and ULPA Filters
The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are designed to catch and remove tiny, airborne particulate matter such as bacteria, pollutants, and dust…
Checks Before and After Installation of HVAC System
HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temperature and humidity sensitive. It also helps to maintain the classified area by controlling the dust particles and microbial load.
Maintenance of Pharmaceutical Clean Area: FDA Recommendation
Maintenance of pharmaceutical clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area.
Working of a HVAC System and Its Functions
Heating, ventilation and air conditioning (HVAC) is the key to ensuring that the pharmaceutical products manufactured by an industry are of good quality. It ensures that there are all the necessary favorable conditions for successful manufacturing.
Buffer Area and Its Maintenance in Sterile Facility
The buffer area is the sterile zone in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as the buffer area. The buffer area is always ISO 7 area (class 10,000) or better air quality.
New Changes in ISO 14644-1:Classification of Air Cleanliness
ISO 14644 Part 1 is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms. This document provides the standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already published in 2011, 2012, 2014 and 2015 but none was finalized and 1999 version was applicable …
Poly Alpha Olefin (PAO) Used in HVAC Validation
Poly Alpha Olefin (PAO) is used for HVAC qualification in pharmaceuticals. PAO is used as a replacement of the DOP (Dioctyl Phthalate) that was used for this purpose for a long time.
