Pharmaceutical Guidelines

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 ...