Archives for December 2017

Compounding Aseptic Containment Isolator from Aseptic Enclosures

We would like to start the New Year by introducing our Compounding Aseptic Containment Isolator. These close isolators provide a better physical barrier to protect the health of laboratory workers, maintain the sterility of experimental materials, and prevent the contamination of the environment. Closed containment cabinets are safer to use in research laboratories to provide a clean work environment, prevent exposure of laboratory personnel, prevent aerosol contamination, avoid pathogenic microorganisms to escape or enter the cabinet, prevent cross-contamination of experiments, and protect the environment.

Happy Holidays

We would like to wish our valued customers a Merry Christmas and a Happy New Year!

Simple Diagnostics, Inc. Issues Voluntary Nationwide Recall of Foshan Flying Medical Alcohol Pads Due to the Lack of Sterility Assurance and Other Quality Issues

For Immediate Release

November 30, 2017

Contact

Consumers

Simple Diagnostics
1-877-342-2385

Announcement

Simple Diagnostics, is voluntarily recalling three lots of Pharmacist Choice Alcohol Prep Pads (UPC # 898302001050, NDC # 98302-0001-05), which were manufactured by Foshan Flying Medical Products Co. Ltd., located in China, due to the lack of sterility assurance and other quality issues.

Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

Early on, the drug substance (DS) manufacturer will provide a wealth of preliminary characterization data. And if the drug is active in early nonclinical and preclinical testing, a larger quantity of the DS will be prepared for more comprehensive animal safety and pharmacokinetics studies. These studies may require up to several hundreds of grams (sometimes a kilo) of purified DS with low levels of impurities and residual solvents that meet global regulatory standards.

FDA Announces Approval, CMS Proposes Coverage Of First Breakthrough-Designated Test To Detect Extensive Number Of Cancer Biomarkers

Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to health care professionals, patients and eligible Medicare beneficiaries‎ sooner

 

Sun Pharmaceutical Industries Inc. Issues Voluntary Nationwide Recall of Riomet® (Metformin Hydrochloride Oral Solution) Manufactured by a Contract Manufacturer due to Microbial Contamination

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” including its subsidiaries and/or associate companies) is voluntarily recalling two lots of Riomet® (Metformin Hydrochloride Oral Solution), 500 mg/5mL, to the retail level (Class II Recall). This product is manufactured for SPII by a contract manufacturer. The Riomet® (Metformin Hydrochloride Oral Solution) has been found to be contaminated (Scopulariopsis brevicaulis). The contamination was discovered during sample preparation for the Antimicrobial Preservative Effectiveness Testing (AMPET) being performed as part of the 12 month stability study interval.

Portable Compounding Cleanrooms

 

 

Aseptic Enclosures, manufacturers of Mobile Compounding Cleanrooms, in compliance with FDA, USP 797 & USP 800 standard. Many hospital pharmacies are undergoing major renovations to be in compliance with new standards. However, they must continue vital drug preparation without interruption. Aseptic Enclosures Mobile Cleanroom allows the hospital to maintain separate, on-site sterile drug compounding operations concurrent to a build-out.

Compounding Pharmacy

Charles River offers FDA-licensed products and cGMP-compliant services to maintain control and consistency in your compounding processes, from in-process testing to batch release.

Pharmacies that prepare individualized dosages of sterile drugs for patients must meet stringent requirements and standards to assure patient safety. Our FDA-licensed products and cGMP-compliant services for compounding pharmacists help maintain control, consistency and reduce risks associated with manufacturing in an aseptic environment.