Media Fill by Aseptic Enclosures

media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.

 

Portable Cleanrooms

The Underappreciated Risks of Hospital IV Compounding

A typical hospital room can be described as a patient lying in a bed with an IV drip bag hanging from a pole. But when you take a closer look at IV administration of fluids and medications, it is so much more than a common task. What can be viewed as an uneventful procedure, even by  health-care professionals, is too often accompanied by major errors.

Longtime Keene pharmacy to close this month

By Sierra Hubbard Sentinel Staff

After nearly 50 years in business, The Apothecary in Keene will close its doors March 30, the business announced in a news release Monday.

Frequently Asked Questions About Pharmaceutical Compounding

What is compounding, and why is it necessary?

Compounding is the creation of a pharmaceutical preparation—a drug—by a licensed pharmacist to meet the unique needs of an individual patient (either human or animal) when a commercially available drug does not meet those needs. A patient may not be able to tolerate the commercially available drug, the exact preparation needed may not be commercially available, or a patient may require a drug that is currently in shortage or discontinued. The U.S. Pharmacopeia Convention (USP) formally defines compounding as “the preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner/patient/ pharmacist/compounder relationship in the course of professional practice.”

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

By Michael Sadick, Ph.D. and Dan Papa, Catalent Biologics

Accelerate Biopharmaceutical Development With Novel Analytical Techniques

Get insights on how Octet-based Fc Receptor Panel test allows for rapidly adaptable assessment of monoclonal antibody therapeutics

Our mobile compounding center featured in the February issue of Pharmacy Purchasing & Products Magazine

Our mobile compounding center was featured in the latest issue of the PP&P Magazine who showcased our plug and play mobile cleanroom as this months’ new and noteworthy addition to the industry.

FDA’s Gottlieb outlines new goals in budget plan, looking to spur drug reviews

President Donald Trump’s budget sought a boost in funding for the FDA and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plans to pursue.

Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital health.

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release

January 29, 2018

Contact

Consumers

Recall Department
recall@kareway.com
310-532-0009

 

Announcement

Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

An Analysis Of FDA FY2017 Drug GMP Warning Letters

By Barbara Unger, Unger Consulting Inc.