The pharmaceutical vial capping process: container closure systems, capping equipment, regulatory framework, and seal quality tests

R Mathaes, HC Mahler, JP Buettiker, H Roehl… - European Journal of …, 2016 - Elsevier
Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …

Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies

H Wolf, T Stauffer, SCY Chen, Y Lee… - PDA Journal of …, 2009 - journal.pda.org
ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages
by Vacuum Decay Method is applicable for leak-testing rigid and semi-rigid non-lidded trays; …

Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)

S Aliaskarisohi, M Hogreve, C Langlois… - PDA Journal of …, 2019 - journal.pda.org
An aerosol microbial ingress test was specifically designed and used to create a predictive
model in order to determine the maximum allowable leakage limit (MALL) of single-use …

Test system and method for flexible containers

R Pavlik - US Patent 9,279,737, 2016 - Google Patents
A portable flexible container integrity test device for conducting integrity testing of flexible
containers is disclosed. The test device is particularly useful for testing aseptic flexible film …

Pharmaceutical container/closure integrity IV: development of an indirect correlation between vacuum decay leak measurement and microbial ingress

LT Nguyen, W Muangsiri, R Schiere… - PDA Journal of …, 1999 - journal.pda.org
The rational development of a physical test method to evaluate the microbial barrier
properties of sterile containers necessitates its correlation to microbiological exclusion. This …

The Pharmaceutical Capping Process—Correlation between Residual Seal Force, Torque Moment, and Flip-off Removal Force

R Mathaes, HC Mahler, L Vorgrimler… - PDA journal of …, 2016 - journal.pda.org
The majority of parenteral drug products are manufactured in glass vials with an elastomeric
rubber stopper and a crimp cap. The vial sealing process is a critical process step during fill …

Package integrity testing

LE Kirsch - Guide to Microbiological Control in Pharmaceuticals …, 2007 - books.google.com
In the past, the packaging of pharmaceutical products often took little account of the
microbiological aspects of maintaining product integrity. This was especially true of …

Elastomeric components for the pharmaceutical industry

EJ Smith - Encyclopedia of pharmaceutical technology. 3rd ed …, 2007 - api.taylorfrancis.com
Pharmaceutical packaging has allowed the widespread distribution of drugs; without it there
would be no pharmaceutical industry and the quality and quantity of life we have come to …

Optodynamic monitoring of the laser drilling of through-holes in glass ampoules

A Babnik, J Diaci - Measurement Science and Technology, 2006 - iopscience.iop.org
We present an accurate and reliable method for the detection of wall perforation during the
excimer-laser micro-drilling of glass ampoules and vials. The method is based on the …

Monitoring of the laser microdrilling of glass by the optodynamic method

R Petkovsek, J Mozina - Journal of Applied Physics, 2007 - pubs.aip.org
During the pulsed-laser microdrilling process using nanosecond pulses, a plasma and a
shockwave develop. In order to study their formation and propagation and investigate the …