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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 …………

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elementary healthcare metrology

ElementaryHealthcareMetrology

Roberto Benitez

Corporacion BH, S.C.

Mexico

elementary healthcare metrology2

ElementaryHealthcareMetrology

7.6 Control of monitoring and measuringdevices

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 metrology3

ElementaryHealthcareMetrology

  • Pharmaceutical Instruments
  • Biomedical Instruments
  • HealthcareMetrologyEducation
pharmaceutical instruments

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 instruments1

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 instruments2

Pharmaceutical Instruments

  • Wednesday, January 4, 2006
  • OFFICIAL GAZETTE
  • MEXICO HEALTH DEPARTMENT
  • OfficialMexican Standard NOM-073-SSA-2005
  • Stability of Drugs and Medicine
pharmaceutical instruments3

Pharmaceutical Instruments

  • Expto 40°C 75% RH 5 d Expto 40°C 75% RH Light 5 d
pharmaceutical instruments4

Pharmaceutical Instruments

  • OFFICIAL GAZETTE
  • MEXICO HEALTH DEPARTMENT
  • ….. theDrugStoreshouldhave a Refrigeratorwith a CalibratedThermometerinside, dailyregisters of theTemperaturebetwen 2 – 8°C and therelatedCalibrationCertificateissuedbyanenterpriseauthorizedbythe NMI.
pharmaceutical instruments5

Pharmaceutical Instruments

….. theDrugStoreshouldhave a Refrigeratorwith a CalibratedThermometerinside.

pharmaceutical instruments6

Pharmaceutical Instruments

….. theDrugStoreshouldhave a Refrigeratorwith a CalibratedThermometerinside.

pharmaceutical instruments7

Pharmaceutical Instruments

  • CONTROL DARK LIGHT
pharmaceutical instruments10

Pharmaceutical Instruments

  • AutomatedDispensingSystems
  • … 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 instruments11

Pharmaceutical Instruments

  • AutomatedDispensingSystems
  • 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 instruments12

Pharmaceutical Instruments

  • AutomatedDispensingSystems
  • The drug is ejected into a strip-packing device where it is labeled and hermetically sealed
biomedical instruments

Biomedical Instruments

  • BodyMassIndex
  • BloodPressure
healthcare metrology education

HealthcareMetrologyEducation

  • HEALTH DEPARTMENT
  • Stability of Drugs and Medicine
healthcare metrology education2

HealthcareMetrologyEducation

  • LetsworkforHealthcareMetrology
  • ThankYou
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