Pharmaceutical Guidelines

Smoke Study in Cleanroom Areas Smoke test is helpful to visualize the air flow pattern in sterile cleanroom areas. Smoke flows according to the flow of air in the area and shows its path. Smoke Study The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from contamination in a processing company. The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow exiting H ig h Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufacturing clean room. The main objective of the smoke study is to observe the pattern that is introduced to observe the airflow pattern and therefore physical properties of the smoke play a visual role in the entire qualification. The smoke study should be conducted by trained personnel with proper safety equipment. When performing the smoke study in clean room area, the styles of smoke used ar...

Sanitation of Cleanroom Area in Pharmaceutical Manufacturing Learn the important things about the sanitation and disinfection of sterile pharmaceutical manufacturing cleanroom areas. Cleanroom Area It is important to maintain and clean the sterile pharmaceutical manufacturing c lean room area periodically. The area should be clean after a defined period as per st andard operating procedure . Where sanitation is done by using the disinfectants , two or more disinfectants should be used. Disinfectants may be ineffective against some of the organisms called re sistant or g anisms . A procedure should be developed to identify such organisms and any e ffective disinfectant should be employed for such organisms. Sanitation procedure and the disinfectant used should be validated. If any equipment is sanitized with the disinfectant, a cl eanin g validation should be done for the removal of the disinfectant. Residues of the disinfectant should be removed properly from the equipment after c...

Role of RH and Temperature in Dry Powder Injection Manufacturing Relative humidity and temperature plays a significant role in pharmaceutical manufacturing and it is a critical parameter in dry powder injection manufacturing. RH Moisture remains to be a great risk to the pharmaceutical industry. Moisture is known to cause deterioration of hygroscopic substances, it activates reactions between containers and the pharmaceutical substances contained in them and it is also known to cause solidification of dry powder injection. Drugs are chemicals and they chemically change when subjected to unfavorable conditions. Due to this, pharmaceutical products should be kept in environments with the right temperatures ranges that will not alter their quality or functionality. But why should RH and temperature be controlled in dry powder injection manufacturing? Find out below the role of RH and temperature in dry powder injection manufacturing.  Moisture in Powder Causes Poor Grinding  In t...

Role and Calculation of Air Changes per Hour in Clean Room Area Determination of the air velocity in CFM and air changes per hour ACPH in pharmaceutical clean rooms and also know its requirements in different cleanroom classes like 100, 1000, 10000, 100000. ACH Air changes in the pharmaceutical clean room play an important role in the maintenance of HVAC clean room quality. Air changes per hour are the number of total replacements of any room’s air in one hour. If the supply of the air by HVAC s y stem in one hour is equal to the volume of the room then it will be one air change per hour. Rooms having 60 air changes per hour will have 60 times air supply then the volume of the room. FDA recommends maintaining the minimum 20 air changes per hour for clean rooms. How to Calculate the Air Changes Per Hour (ACPH Formula): First of all, determine the velocity of the air below the HEPA filter in feet per minute. It is determined at the four corners and the center of the filter and the me...

Restricted Access Barrier System (RABS) in Pharmaceuticals Restricted Access Barrier Systems are very useful in sterile pharmaceutical manufacturing to maintain the sterility of the products. (RABS) The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. RABS process in an ISO 5 environment, similar to i solators . RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the intervention recorded. RABS allows for faster start- ups and easier and quicker changeover. Restricted Access Barrier Systems also can accept certain restrictions and offer increased operational flexibility. Most pharmacies choose RABS over Isolators because they are quicker in the changeover process. Like laminar flow hoods (LFHs), RABS feeds clean air from fan units through HEPA f ilters and...

Requirement of Active and Passive Air Sampling in Controlled Areas Air sampling is a mandatory procedure to be followed in pharmaceuticals to produce the contamination free quality product. Contamination Of Products What would you say if I ask for the causes the most contamination of products during the manufacture of pharmaceuticals? If you’re like me, 'people' was the first thought that came to mind. You and I both are right, in fact; people, raw materials, and water are one of the main contaminants of products according to most microbiologists. However, air is another key source of contamination that most pharmaceutical facilities often ignore to take precaution from. Air particulate sampling or air monitoring is essential for Qu ali ty Control (QC) purposes especially in companies that manufacture pharmaceutical products in controlled areas or clean rooms with filtered air. Bioburden Well, what pharmacists, health care practitioners, and microbiologists refer to as air sa...

Pyrogen Test and Its Determination Using Rabbits Learn how to determine the pyrogen in parenteral preparations by injecting the sample in rabbits for pyrogen testing. Introduction: Pyrogen test is performed to check the presence or absence of pyrogens in all aqueous p arenterals . Rabbits are used to perform the test because their body temperature increases when pyrogen is introduced by the parenteral route. For this test, three healthy rabbits are selected each weighing at least 1.5 kg. No rabbit should be selected if: It has a normal temperature greater than 49.8°C. It was used in a positive test during last two weeks or negative test during last two days. Method for Pyrogen Test: The pyrogen testing is performed in an air-conditioned room. The food and water is withheld to rabbit overnight. A clinical thermometer is inserted in the rectum of each rabbit to a depth of not less than 7.5 cm. Two readings of the temperature of rabbit in normal conditions should be taken at the interval ...