Optimizing Ethylene Oxide Sterilization: Key Considerations for Medical Device Manufacturers

Microbiology

Optimizing Ethylene Oxide Sterilization: Key Considerations for Medical Device Manufacturers. Medical device manufacturers face stringent regulations and requirements for ensuring the safety and effectiveness of their products. Ethylene oxide (EO) sterilization is a commonly used method for sterilizing medical devices, but it requires careful consideration to ensure optimal outcomes. Here are key considerations for optimizing …

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Production of sterile pharmaceutical products

Aseptic Processing Guidelines

In the pharmaceutical industry, the production of sterile products is critical to ensuring the safety and efficacy of medications. Sterile products are those that are free from living organisms and are not contaminated with harmful microorganisms. The process of producing sterile products is called aseptic manufacturing. Aseptic manufacturing involves the use of sterile equipment, sterile …

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SOP For for Testing Container Closure Integrity by Microbial Ingression

Aseptic Processing Guidelines, Microbiology

The SOP for testing container closure integrity by microbial ingression appears to be well-structured and organized. It includes the purpose, scope, responsibility, accountability, and detailed procedure for testing. The procedure mentions the use of a biosafety cabinet, sterile hand gloves, fresh sterile pipettes, and disinfectant for handling cultures, which is necessary to maintain the sterility …

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Critical quality attributes (CQAs) in the compression stage of tablet manufacturing

Quality Assurance

The compression stage is a critical step in the tablet manufacturing process. During this stage, the powders or granules that have been blended and mixed in the previous stages are compressed into tablets using a tablet press machine. The compression process involves applying high pressure to the powder mixture, which forms the tablet and gives …

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Hold Time Study Report for Dirty Equipment in the Injection Ampoule Section

Quality Assurance

A hold time study report is an essential part of the quality control process that determines the maximum time for which a product can be held or stored under specified conditions. In the case of dirty equipment in the injection ampoule section, this study is critical for ensuring that the equipment does not introduce contamination …

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Aurobindo Pharmaceutical USFDA Warning Letter- 2022

FDA Warning Letter

Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — JANUARY 12, 2022 January 12, 2022 WARNING LETTER Delivery Method:VIA UPSProduct:Drugs  Recipient: Mr. Narayanan GovindarajanAurobindo Pharmaceutical Limited Floor No.’s 22, 23 & 24 Galaxy Plot No-1, Survey No: 83/1, Hyderabad Knowledge City Raidurg Panmaktha, Ranga Reddy District Hyderabad500081 Telangana IndiaIssuing Office:Center for Drug Evaluation and Research | CDER United States Warning Letter 320-22-10 January …

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