Elementary Healthcare Metrology Roberto Benitez Corporacion BH, S.C. Mexico

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

Automated Dispensing Systems … are drug storage devices or cabinets that electronically dispense medications in a controlled fashion and track medication use. … 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. 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. 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. 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 The drug is ejected into a strip-packing device where it is labeled and hermetically sealed

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