Michael Drummond - Malvern PA, US Albert Moses - West Chester PA, US
Assignee:
Drummond Scientific Company - Broomall PA
International Classification:
G01K 1/02
US Classification:
116217000
Abstract:
An apparatus that indicates whether an object has been exposed to a predetermined critical temperature T. The apparatus housing has a reservoir portion and a capillary tube portion in fluid connection with the reservoir portion. A first fluid is contained within the reservoir portion. A second fluid is contained within the capillary portion. A barrier is located intermediate the first fluid and second fluid. The barrier prevents the first and second fluids from intermixing until the apparatus is exposed to the critical temperature, and then allows at least a portion of the second fluid to mix with the first fluid when the apparatus is exposed to the critical temperature. An observable characteristic of one of the fluids irreversibly changes when the apparatus is exposed to the critical temperature. The housing completely encapsulates the fluids and barrier within the housing and prevents evaporation of the fluids and barrier from the housing.
A disposable, contamination-indicating pipette for metering liquids containing a specified agent. The pipette has a main body portion having a volume V and a diameter D, an open-ended upper connection portion, and an open-ended lower tip portion. An indicator in the connection portion provides an observable indication that liquid has entered the connection portion.
Dual-Temperature, Sealed-System Critical Temperature Indicator
Albert J. Moses - West Chester PA, US Michael E. Drummond - Broomall PA, US
Assignee:
Drummond Scientific Company - Broomall PA
International Classification:
G01K 1/02
US Classification:
116216
Abstract:
An inexpensive, disposable apparatus that visually indicates whether an object has been exposed to either one or both of two predetermined critical temperatures such as a critical high T or a critical low T temperature. The apparatus includes a housing having a reservoir portion, and a capillary tube portion with a first, proximal end in fluid connection with the reservoir portion and an open, second, distal end. A first fluid is contained within the reservoir portion and a portion of the proximal capillary tube portion. A second fluid is contained within the capillary portion intermediate the first fluid and the distal end. A barrier is located intermediate the first fluid and the second fluid. The barrier prevents the first and second fluids from intermixing until the apparatus is exposed to T and then allows at least a portion of the second fluid to mix with the first fluid when the apparatus is exposed to T and irreversibly changes an observable characteristic of the second fluid. An indicator material is fixed proximate to and in fluid communication with the distal end of the capillary tube portion. The indicator material has an observable characteristic that irreversibly changes at T when contacted with the second fluid. An outer sheath encapsulates the indicator and the distal open end of the capillary tube portion to prevent the fluids and barrier from evaporating from the housing.
Teva Pharmaceuticals
Senior Director, Medical Device and Combination Products Quality at Teva Pharmaceuticals
Streck Aug 2009 - May 2012
Director of Quality and Regulatory
Drummond Scientific Co Jun 1992 - Aug 2009
Director of Quality and Regulatory Compliance
Centocor 1986 - 1992
Iqa Unit Manager
Education:
West Chester University of Pennsylvania
Bachelors, Bachelor of Science, Biology
West Chester University of Pennsylvania
Master of Business Administration, Masters, Bachelors, Bachelor of Science
Skills:
Quality System Quality Auditing Fda Medical Devices Iso 13485 Gmp Iso Pharmaceutical Industry Change Control 21 Cfr Part 11 Capa Process Improvement Regulatory Submissions Validation Regulatory Affairs Drug Delivery U.s. Food and Drug Administration Iso 14971 Contract Negotiation Glp Ivd V&V Gxp Regulatory Requirements Verification and Validation Combination Products European Union Design Control Business Process Improvement 21 Cfr Part 820 Pen Injectors Needle Based Injection Systems In Vitro Diagnostics 21 Cfr Part 4 Quality Assurance Quality Control