Manufacturing

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Articles

INTERPHEX presents advances in pharmaceutical container filling, robotic handling, and serialization. 

New Equipment and Software Meet Needs for Fill/Finish, Serialization, and Data Traceability

New filling and inspection machines and new containers and closures for injectable drugs will be on display at INTERPHEX 2018.

Parenteral Packaging Innovations

Daniela Neubert is liquid chromatography analyst at OFI Technologie & Innovation GmbH in Vienna.

Nicole Steiner-ReischÃ¼tz is coordinator at OFI Technologie & Innovation GmbH in Vienna.

Michael Pyerin is head of pharma, medical devices, and hygiene at OFI Technologie & Innovation GmbH in Vienna.

Michael WashÃ¼ttl is head of packaging at OFI Technologie & Innovation GmbH in Vienna.

Michael Krainz is project manager for packaging at OFI Technologie & Innovation GmbH in Vienna.

Chrysoula Kanakaki is GC chromatography analyst at OFI Technologie & Innovation GmbH in Vienna.

Research suggests that radiation can have a significant impact on the composition and rheology of hydroxyethyl cellulose-based medicinal gels.

Evaluating the Impact of Sterilization on Gel Formulations

The CDMO’s new blow-fill-seal machinery at its Kaysersberg site is now operational. 

Recipharm Completes Blow-Fill-Seal Expansion at Kaysersberg Facility

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing.  The authors included a brief summary of the comments developed on the draft document.  This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft. 

Annex 1 Misses the Mark–Expanded Version

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

USP Cancels Revisions to Packaging Chapters

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.

Considerations for Seals in Split Butterfly Valves

The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.

Hospira Recalls Labetalol Hydrochloride Due to Cracked Vials

FDA sent a warning letter to Celltrion detailing CGMP violations, including poor microbial contamination control.

Poor Aseptic Practices Found at Korean Facility

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

Aseptic/Sterile Processing