Aseptic/Sterile Processing

Gottlieb Supports Compounded Drugs

September 27, 2017

The FDA commissioner made a statement about the agency’s efforts to ensure patient access to safe compounded medicines.

Aseptic Fill/Finish Line for Drug Product Manufacturing

August 25, 2017

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

Compounding Pharmacy Warned About Unsterile Conditions

August 18, 2017

FDA sent a warning letter to Maple Rose Enterprises, Inc., dba Pencol Compounding Pharmacy, citing the company for violations of sterile manufacturing practices.

Testing and Sterility Deficiencies Found at Illinois Facility

July 25, 2017

FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.

Tubilux Pharma S.p.A. Receives FDA Warning Letter

July 18, 2017

The agency cited the Italian company for aseptic processing failures.

Forty Years of Drug Product Manufacturing Advances

July 02, 2017

Oral solid-dosage and parenteral drug manufacturing equipment and systems have made great strides in safety and efficiency.

Perspective: Consolidation Shapes Pharma

July 02, 2017

Pharma company consolidation and outsourcing led to a de-emphasis of manufacturing and reduced investment in new technologies and facilities.

Perspective: Biologics Advance the Pharma Industry

July 02, 2017

Advancements in cell culture and protein technology have opened the door for new therapies.

Hospira Sterility Problems Cause Another Recall

June 26, 2017

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

Looking at Trends in Parenteral Manufacturing

June 21, 2017

Equipment and Processing Report

The need for flexibility and higher quality are driving advances in parenteral manufacturing and fill/finish equipment.