Transcript Elementary Healthcare Metrology

Elementary Healthcare Metrology
Roberto Benitez
Corporacion BH, S.C.
Mexico
Elementary Healthcare Metrology
Elementary Healthcare Metrology
7.6 Control of monitoring and measuring devices
The organization shall …………
Where necessary to ensure valid results, measuring
equipment shall
a).- be calibrated or verified at specific intervals, or prior
to use, against measurement standards traceable to
international or national measurement standards; where no
such standards exist, the basis used for calibration or
verification shall be recorded.
ISO/TS 16949:2002
Elementary Healthcare Metrology
Pharmaceutical Instruments
- Biomedical Instruments
- Healthcare Metrology Education
-
Pharmaceutical Instruments
Work on stability of pharmaceutical products was
initiated by WHO in 1988 and the WHO Guidelines
on Stability Testing for Well Established Drug Substances
in Conventional Dosage Forms were adopted in 1996
by the WHO Expert Committee on Specifications
for Pharmaceutical Preparations following extensive
consultation.
Pharmaceutical Instruments
WHO has formulated international regulatory
standards on several quality related issues, which
include
stability,
packaging,
storage,
and
bioequivalence. Care must be taken to ensure that
active pharmaceutical compounds remain stable and
unaffected by packaging materials or storage
conditions.
Pharmaceutical Instruments
Wednesday, January 4, 2006
OFFICIAL GAZETTE
MEXICO
HEALTH DEPARTMENT
Official Mexican Standard NOM-073-SSA-2005
Stability of Drugs and Medicine
Pharmaceutical Instruments
Exp to 40°C 75% RH 5 d
Exp to 40°C 75% RH Light 5 d
Pharmaceutical Instruments
OFFICIAL GAZETTE
MEXICO
HEALTH DEPARTMENT
….. the Drug Store should have a Refrigerator with a
Calibrated Thermometer inside, daily registers of the
Temperature betwen 2 – 8°C and the related
Calibration Certificate issued by an enterprise
authorized by the NMI.
Pharmaceutical Instruments
….. the Drug Store should have a Refrigerator with a
Calibrated Thermometer inside.
Pharmaceutical Instruments
….. the Drug Store should have a Refrigerator with a
Calibrated Thermometer inside.
Pharmaceutical Instruments
CONTROL
DARK
LIGHT
Pharmaceutical Instruments
Pharmaceutical Instruments
Pharmaceutical Instruments
Automated Dispensing Systems
… are drug storage devices or cabinets that
electronically dispense medications in a controlled
fashion and track medication use.
•
Centralized pharmacies prepare and distribute
medications from a central location within the
hospital.
•
Pharmaceutical Instruments
Automated Dispensing Systems
Medications are stored in calibrated canisters
that are designed specifically for each medication.
•
Canisters are assigned a numbered location,
which is thought to reduce mix-up errors upon
dispensing. When an order is sent to the
microcomputer, a tablet is dispensed from a
particular canister.
•
Pharmaceutical Instruments
Automated Dispensing Systems
• The
drug is ejected into a strip-packing device
where it is labeled and hermetically sealed
Pharmaceutical Instruments
Pharmaceutical Instruments
Pharmaceutical Instruments
Pharmaceutical Instruments
Pharmaceutical Instruments
Biomedical Instruments
Body Mass Index
Blood Pressure
Biomedical Instruments
Blood Pressure
Healthcare Metrology Education
HEALTH DEPARTMENT
Stability of Drugs and Medicine
Healthcare Metrology Education
HEALTH DEPARTMENT
Healthcare Metrology Education
Lets work for Healthcare Metrology
Thank You