Pharmaceutical Guidelines

Sterility Testing by Direct Inoculation Method Direct Inoculation Method Learn the procedure for sterility test for sterile pharmaceutical products by direct inoculation method. 1.0 Objective :  To lay down Standard Operating Procedure is to provide guidelines for sterility testing by Direct Inoculation Method. 2.0 Scope This procedure is applicable for the products manufactured at the location which can not be tested by Membrane Filtration Method. 3.0 Responsibility Implementation: Microbiologist 4.0 Accountability Execution: Manager - QC Review & Approval : AGM - QA / QC Procedure Direct Inoculation Method Sample for Finished Products: Collect the samples to be tested for sterility. Out of the whole sample, randomly select 20 articles of each lot of batch for both LVP and SVP t erminal ly sterilized products and for aseptically filled products.    Sample for Intermediates: Randomly collect 16 pre-sterilized bottle samples to be tested for sterility from LVP bot...

Sterile Pharmaceutical Dosage Forms - Parenteral Preparations                    Learn all about Parenteral preparations including Injections, Powders for Injection, Infusions, Concentrated Solutions for Injection and Implants. Introduction Parenteral Preparations Parenteral preparations are sterile products those are administrated by injection into the body. They may be directly administrated or they may be diluted before administration. Production of Parenteral Products P arenteral preparations are prepared by the methods that maintain their  Sterile , avoid the introduction contaminants and microbial growth. The Parenteral preparations those are in the form of liquids require the base to dissolve them. W ater for In j ection is commonly used in Parenteral preparations. Any other suitable base may be used provided they are safe in the volume of injections administered and also do not interfere with the therapeutic effica...

Sterile Area (Cleanroom) Qualification Sterile area validation has different tests like air supply, air velocity, air changes, flow pattern, filter integrity, pressure test, particle count, temperature, recovery test, microbial count, relative humidity, noise level and vibration test. Sterile Area Sterile area qualification and HVAC system qualification are two different things but most of the tests are same because HVAC system is qualified by its performance as the quality of the area. Qualification document of the HVAC system and the sterile area should be prepared separately. The sterile area can be qualified by applying following tests. 1.0 Air supply capacity: The purpose of this test to demonstrate that the air system is balanced and capable of delivering sufficient air volumes (as per design) to maintain required air change (NLT 20) in the defined area. The air capacity will be demonstrated by following the procedure of: Measure airflow in supply and returned duct Air volume to ...

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...