Pharmaceutical Guidelines

Preparation Process for Water for Injection (WFI) in Pharmaceuticals Water for injection is used in sterile manufacturing and its preparation and storage is a critical process. There are basically two types of water preparation in pharmaceuticals. Water for Injection (WFI) preparation process and purified water preparation process. The analytical standards for the two water are almost very similar, the only difference is that Water for Injection (WFI) system in pharmaceuticals has stricter bacterial control standards than USP standards for purified water process and has to pass the bacterial endotoxin test. Preparation methods are very similar to a particular point, however, Water for Injection (WFI) preparation process in pharmaceuticals must include distillation or double pass reverse osmosis techniques. Dechlorination: This refers to the removal of chlorine from the water. There are several ways of dechlorination.This include injection of a reducing agent like sodium metabisulfite a...

Possibilities of Contamination in Sterile Products Contamination in sterile products is a serious problem in sterile manufacturing. It should be handled carefully to produce the quality products. In pharmaceutical production, the term "sterile products" is usually used to describe parenteral preparations. These are products which are not meant to be administered via oral route or alimentary canal, so do not benefit from the protection of the immune system which the alimentary canal provides. Administration of these drugs is done directly to the blood stream or various body tissues.  Pa renteral products include but are not limited to intravenous fluids, intramuscular injections, and optical solutions. Since these products will not pass through the digestive system, any contamination may mean very serious consequences to patients. For this reason, sterility assurance for such parenteral products is sacrosanct and must be achieved using standard g ood manufacturing practice ....

Poly Alpha Olefin (PAO) Used in HVAC Validation Know more about the Polyalphaolefin (PAO) used in HEPA filter integrity test during HVAC system qualification including their molecular structure. Poly Alpha Olefin (PAO) is used for HV AC qualification in pharmaceuticals. PAO is used as a replacement of the DOP (Dioctyl Phthalate) that was used for this purpose for a long time. Dioctyl Phthalate is found as a carcinogen (cause cancer) for the human. Scientists were trying to find a material to replace the DOP for a long time. Finally in 2001 Japan Air Cleaning Association (JACA) published a guideline to replace the DOP with PAO. It gives the equal performance to the DOP and doesn’t have any harmful effect on health. FDA also clearly says that alternative aerosols are also acceptable but they should not promote the microbial growth in the area. Therefore, it is recommended to replace the Dioctyl Phthalate with Poly Alpha Olefin (CAS #68649-12-7). The size of PAO generated aerosol ran...

Personnel Monitoring in Sterile Area Learn how to monitor the personnel hygene in Sterile Area. 1.0 Equipment Required Sterile dress  Clean SS container 2.0 Material Required Sterile SCDA plates Sterile 70% IPA solution Procedure Prepare SCDA medium as per SOP for preparation of culture media and aseptically pour approximately 15 – 20 ml of sterile molten cooled (40°C) SCDA agar into sterile 90 mm Petri plates. Allow solidifying the plates under LAF, after solidification label all the plates with the name of media, preparation batch No. and date of preparation. Invert and incubate the plates at 30 to 35°C for 24 hrs. After incubation check the plates for any c ontamination , if there is contamination discard the plates as per SO P for Destruction of Microbial waste b y Autoclaving . After pre-incubation, label all the plates with the date of sampling, Personnel name and Shift with the help of marker pen and wrap with aluminum foil and then keep in a clean s tainless steel contain...

Performance Qualification of Isolator Systems Learn how to validate the Isolator Systems for Air velocity, HEPA Filters Integrity, Differential Pressure Test and Non Viable Particulate in Pharmaceutical manufacturing. PROCEDURE Validation Test Procedure: The HV AC s y stem will be considered qualified for consistent and reliable performance (Validated) on successful completion of the following tests. Air velocity measurement studies Integrity testing of HEPA filters Differential pressure monitoring Non-viable particulate monitoring Power failure recovery study Airflow direction Microbial monitoring Lighting and sound level monitoring Temperature and RH monitoring Bio-decontamination study Chamber leak test To qualify the System, above tests should fulfill the acceptance criteria described in the individual test procedures. After completion of the qualification tests, all the data generated will be compiled together to evaluate the ability of the isolator system to maintain the des...