There was a time glove testing wasn´t much fun.. but that’s history…
Glove Leak Testing in Isolators and RABS and what the regulators say about it:
FDA Aseptic Processing Guidance
APPENDIX 1: ASEPTIC PROCESSING ISOLATORS
- Glove Integrity
A faulty glove or sleeve (gauntlet) assembly represents a route of contamination and a critical breach of isolator integrity. A preventative maintenance program should be established. The choice of durable glove materials, coupled with a well-justified replacement frequency, are key aspects of good manufacturing practice to be addressed. With every use, gloves should be visually evaluated for any macroscopic physical defect. Physical integrity tests should also be performed routinely. A breach in glove integrity can be of serious consequence. The monitoring and maintenance program should identify and eliminate any glove lacking integrity and minimize the possibility of placing a sterile product at risk. Due to the potential for microbial migration through microscopic holes in gloves and the lack of a highly sensitive glove integrity test, we recommend affording attention to the sanitary quality of the inner surface of the installed glove and to integrating the use of a second pair of thin gloves.
- Routine and frequent leak testing of glove / sleeve system is highly recommended.
The Bosch KHD 3000 is a smart way to handle glove testing and optimizes the time required to perform such testing. It´s specifically designed to be used in Grade B, C and D Cleanrooms and it is easy to clean.
The very compact and flat design combines state-of-the-art-solutions with ergonomics. Ease-of-use and flexibility are improved through Wireless LAN technology, utilizing the latest IT security standards.
The batteries are rechargeable, exchangeable, and will perform six (6) to eight (8) test cycles.
Through the use of RFID technology, glove and port identification is automatic and fail-safe.
- Available as stand-alone version (with dedicated HMI) or totally integrated in production line HMI.
- Fully automatic 3-step testing procedure – Pressure decay principle according to ISO 14644-7
- Automated Inflation of Glove to specific pressure with integrated pump – no additional utilities (e.g. compressed air) necessary
- Stabilization of Glove: Pre-Stretching of glove due to specific stretching properties of glove material
- Measurement: Actual measurement over time. There is a glove specific time-pressure curve as an acceptance criteria (e.g. 1100 Pa for Standard Isolator glove)
- Reliable detection for hole diameters down to 100μm
- Parallel measurement of up to 35 gloves to reduce changeover time
- Short testing procedure starting at 15 minutes (depending on glove material)
- Easy handling of glove test-lid, just 2 buttons – One for On/Off (fixing lid by inflatable sealing) and one for starting the test procedure.
The test procedure is explained by the graph and the parameters are recipe values related to the specific gloves to be tested. After a stabilizing phase, gloves are tested by pressure decay in a defined time frame. The gloves which lose pressure too fast do not pass the test.
Please find our product brochure attached here.
About the Authors:
Jürgen Metzger is Barrier Systems & Process Specialist at Robert Bosch Packaging Technology, Inc.
Jamie Schroetter is Business Development Manager at Bosch Packaging Services
For more information about our Glove Testing capabilities, in North America please contact: Jamie Schroetter