MICROBIOLOGY AND NEW TECHNOLOGY HOW TECHNOLOGY CAN IMPACT ON MICROBIOLOGICAL CONTROL

Transcription

1 MICROBIOLOGY AND NEW TECHNOLOGY HOW TECHNOLOGY CAN IMPACT ON MICROBIOLOGICAL CONTROL

2 DISCUSSION AREAS HOW MICROBIOLOGY NEEDS TO CHANGE TO MEET FUTURE DEMANDS AND PRODUCTION SYSTEMS MICROBIOLOGY AND PAT ON LINE VERSUS OFF LINE SYSTEMS EXAMPLES OF NEAR FUTURE TECHNOLOGIES - BENEFITS AND RESTRICTIONS LONG TERM SYSTEM POSSIBILITIES ELIMINATION OF MICROBIOLOGICAL TESTING BARRIERS TO THE INTRODUCTION AND ADOPTIONS OF NEW TECHNOLOGIES AND ALTERNATIVE APPROACHES

3 WHERE IS MICROBIOLOGY GOING BUSINESS LANDSCAPE IS CHANGING ACCELERATING PACE CONSUMER AWARENESS IS HIGH RECALLS, MEDIA, SOCIAL NETWORKS GLOBAL SUPPLY BIO-DERIVED MATERIALS `NATURAL` INHERENT BIOBURDEN GROWTH IN SHIPMENT IMPACT OF REGULATIONS NEW TECHNOLOGY AND NEW PRODUCT FORMS - SINGLE USE RISK ASSESSMENT IS THE KEY

4 MICROBIOLOGY AND BUSINESS NEEDS PRODUCT SAFETY AND INTEGRITY VS BUSINESS FLEXIBILITY AND COST RESPONSIVENESS INVENTORY CONTROL E COMMERCE MINIMAL BATCH RUNS INCUBATION TIMES SENSITIVITY VS SPEED CUSTOMIZATION

5 CONSUMER AWARENESS FACTOR IN REDUCING PRESERVATIVES? ACCEPTANCE AND USE OF PRESERVATIVE FREE DESIGNS - UNIT DOSE ZERO RISK TOLERANCE -ALTERNATIVE PRODUCTS AVAILABLE PERCEIVED AND PROVEN HEALTH RISKS GENERAL LACK OF UNDERSTANDING OF RISKS EXPECTATION OF GLOBAL STANDARDS OF PRODUCTION CUSTOMIZED PRODUCTS FOR DEVELOPING MARKETS - MAY BE ADVANTAGEOUS SACHETS UNIT DOSE

6 MICROBIOLOGY NEED TO CHANGE ONCE SIZE DOES NOT FIT ALL PLATE COUNTS GOLD STANDARD?? ISOLATE, ENUMERATE, IDENTIFY NEED TO ASSESS RISKS, MATERIALS, PROCESS, ENVIRONMENT, PRODUCT AND TESTS ANALYTICAL SPEED FOR RESULTS TEST METHODS - DRIVING COST AND COMPLEXITY OF MICRO LABS INCUBATE AND DIE LEARN FROM OTHER INDUSTRIES

7 EXAMPLE VALIDATION OF SANITIZATION CLEAN EQUIPMENT, DISMANTLE AND CHECK FOR CLEANING REASSEMBLE, SANITIZE - TEMPERATURE OF CHEMICALS DISMANTLE AND SWAB FOR MICRO TESTING RECOVERY STUDIES FOR SWABS TRAINING OF INDIVIDUALS ETC. REASSEMBLE AND SANITIZE (IN CASE CONTAMINATED DURING SWABBING ) WAIT 3-5 DAYS FOR RESULTS. REPEAT PROCESS 3 TIMES REPEAT ON ALL SYSTEMS,

8 EXAMPLES - VALIDATION OF SANITIZATION ALTERNATIVE APPROACH CLEAN EQUIPMENT, INSPECT WITH BOROSCOPE INFRA RED SURFACE ANALYZE FOR RESIDUES SANITIZE AND MONITOR TEMPERATURES UTILIZE D&Z VALUE DATA FOR SURFACE. MEET TEMPERATURE TIME REQUIREMENTS REPEAT 3 TIMES

9 EXAMPLES - VALIDATION OF SANITIZATION ADVANTAGES SPEED PROACTIVE VALIDATION REDUCED DOWNTIME REDUCED COMPLEXITY AND INTERVENTIONS REDUCED VARIABILITY SWAB RECOVERY MEDIA CHOICE EQUIPMENT REASSEMBLY POSSIBLE INTEGRATION OF SANITIZATION INTO PROCESS CONTROL

10 EXAMPLES - DESIGN IN CONTROL - FACILITIES, EQUIPMENT ETC. RIGHT FACILITIES, RIGHT EQUIPMENT, RIGHT MATERIALS REDUCED NEED FOR TESTING, PREDICTABLE OUTPUT MORE VALIDATION, LESS ROUTINE TESTING INTEGRATED APPROACH SUPPLIERS AND MANUFACTURES FACILITIES CONTROLLED ENVIRONMENT - REDUCE EXPOSURE - UNDERSTAND RISK CLEANING AND MAINTENANCE - REGULAR CLEANING, DISINFECTION, IN LINE MEASUREMENT,MINIMUM MAINTENANCE CROSS OVER CONTAMINATION - PRESSURE DIFFERENTIAL, SEGREGATION AND SEPARATION MATERIALS FLOWS AND TRANSPORT

11 EXAMPLES - DESIGN IN CONTROL - FACILITIES, EQUIPMENT ETC. EQUIPMENT, MATERIALS SIMPLIFIED DESIGN BASED ON UNDERSTANDING KEY CONTROL PARAMETERS CONTINUOUS VS BATCH, LATE STAGE DIFFERENTIATION ELIMINATION OF MANUAL DISPENSING /DOSING INTEGRATED CLEANING (AND SANITIZING ) PROCEDURES IMPROVED SURFACE FINISHES/TREATMENT - OMNIPHOBIC ON LINE TESTING REDUCED SAMPLING POINTS CLEAR UNDERSTANDING OF HOSTILITY TESTING, MATERIALS CHOICES IN DEVELOPMENT APPROPRIATE SPECIFICATIONS - RISK ASSESSMENTS - UNDERSTANDING AND CONTROL OF INGRESS POINTS CONTROLLED UNLOADING SYSTEMS CONTROL STEPS, FILTRATION ETC.

12 EXAMPLES - USE OF RAPID METHODS CURRENT RAPID METHODS - ATP, ENHANCED VISION, O2 DETECTION ALL REQUIRE INCUBATION. USUALLY REQUIRE A MICRO LAB - SAMPLING AND TRANSPORTATIONS RELY ON GROWTH - FASTER DETECTION FITS WITH CONVENTIONAL SPECIFICATIONS BASED ON GROWTH - CFU /GRAM OR ML REDUCED TIME COMPARED TO PLATE COUNTS BUT FAST ENOUGH? SAMPLING INTRODUCES VARIABILITY, MICRO TESTS NEED TO BE COMPLETED IN MINUTES - EFFECTIVE CONTROL MINIMIZES V CHANCE FOR GROWTH REDUCED VARIABILITY

13 EXAMPLES - USE OF RAPID METHODS NEED IN LINE REAL TIME OR NEAR REAL TIME METHODS. ANALYTICAL SPEED METHODS FASTER RESPONSE AND CONTROL FITS WITH DESIGNED IN CONTROL METHODS EXIST OR BEING DEVELOPED REGULATORY ENCOURAGEMENT /ACCEPTANCE REAL TIME AIRBORNE MONITORING SYSTEMS - BIOTRAK RMM ENVIRONMENTAL CONTROL /MONITORING REAL TIME WATER ANALYSIS - METTLER RMS2000, BIOVIGILANT SYSTEM MATERIAL CONTROL /MONITORING FLOW CYTOMETRY - COUNT VIABLE CELLS CHEMUNEX SYSTEMS LIMITED APPLICATION BUT SIGNIFICANT POTENTIAL

14 Examples - Use of Rapid methods IN LINE SAMPLING SYSTEMS FOR WATER - SENTINEL SYSTEMS REDUCED RISK, COMPLEXITY AND TIME BACKUP TESTING FOR ONLINE SYSTEMS CONVENTIONAL METHODS APPLICATION FOR MDM PROGRAMS MATERIALS AND PRODUCTS INCREASED PRODUCTIVITY

15 Examples - Use of Rapid methods IDENTIFICATION SYSTEMS MASS SPECTROMETRY MALDI -TOF STEP CHANGE IN CONVENTIONAL IDENTIFICATION SAME TIME AS GRAM STAIN SPECIES IDENTIFICATION BETTER SPECIFICATIONS AND RELEASE DECISIONS ALLOWS EASY BIO - MAPPING - UNDERSTAND RESIDENT/TRANSITORY ORGANISMS HELPS FOCUS DESIGNED IN CONTROL UNIT COST SEEN AS A NEGATIVE - NEED TOO THINK INTEGRATED AND HOLISTIC DATABASE QUALITY IS KEY - LINK TO GENOTYPIC ID S

16 WHAT HAPPENS TO CONVENTIONAL METHODS FOCUSED USE VERIFICATION/ TRANSITION NEED TO MAKE LIMITATIONS TRANSPARENT TO DEFINE USE HISTORICAL DATABASE SO USEFUL REFERENCE TO TEST NEW METHODS REGULATORY REQUIREMENTS - TOLD TO USE, EQUIVALENCY TESTING COULD BE DIFFICULT - CFU VS CELLS TEND TO BE LOW COST AND SIMPLE - WELL LIKED $$$$$ USEFUL FOR NON TIME DEPENDENT TESTING, EM, MDM, SURFACE TESTING ETC.

17 EXAMPLES - ELIMINATION OF MICRO TESTING PRESERVATIVE REDUCTION AND AVAILABILITY INCREASED SUSCEPTIBILITY ALTERNATIVE STRATEGY HOSTILE PRODUCTS UNFAVORABLE CONSUMER REACTIONS ASEPTIC PRODUCTION AND PACKAGING EXPENSIVE PASTUERIZATION / KILL STEPS NOT APPLICABLE TO ALL PRODUCT TYPES CHEAP, SIMPLE AND EFFECTIVE

18 TERMINAL STERILIZATION PASTEURIZATION FLASH PASTEURIZATION PRIOR TO FILLING HACCP PROCESS BIOBURDEN CONTROL OF INCOMING MATERIALS EXISTING TECHNOLOGY TO CALCULATE D&Z VALUES WELL UNDERSTOOD AND PROVEN PRODUCT NEEDS TO TOLERATE PROCESS ENZYMES, THICKENERS ETC. WOULD YOU NEED TO TEST PRODUCTS?

19 OTHER POTENTIAL STERILIZING TECHNOLOGIES IRRADIATION - COBALT 60 AND E- BEAM LIMITED SCOPE PRODUCT INTERACTIONS FILTRATION - 0.2/0.45 MICRON WATER THIN LIQUIDS COLD PLASMA DRY PRODUCTS, PACKAGING GAS STERILIZATION ETO.H 2 O 2 CONSUMER PERCEPTION - GOOD AND BAD

20 PARAMETRIC CONTROL CONTROL OF VARIABLES MULTI FACETED REAL TIME CONTROL HOT WATER SYSTEMS - TEMPERATURE CONTROL COMPRESSED AIR - DEW POINT IRRADIATED MATERIALS - CERTIFICATION PROCESSING - KILL STEPS HACCP BASED STRATEGIES TO ELIMINATE TESTING

21 PARAMETRIC CONTROL INGREDIENTS AND PACKAGING TEST AND RELEASE STERILIZATION/PASTEURIZATION CONTROL OF THE ENVIRONMENT - STANDARDS CONTROL OF THE PEOPLE- INTERACTION WITH PRODUCTS MANUAL STEPS CLOSED PROCESS CONTINUOUS VS BATCH PROCESS RANDOM EVENTS

22 BARRIERS TO NEW TECHNOLOGY CULTURE - MICROBIOLOGISTS UNWILLINGNESS TO CHANGE PERCEIVED ADDITIONAL COSTS - PLATE COUNTS ARE CHEAP LACK OF HOLISTIC PERSPECTIVE, FACILITIES STAFF, TRAINING, MEDIAL ETC. REGULATORS WILL NOT LIKE IT NEW METHOD ARE MORE SENSITIVE - CAN WE DEAL WITH THE RESULTS VALIDATION IS SO MUCH WORK SENSITIVITY OR SPECIFICITY OF THE METHODS CONFIDENCE IN METHODS THE PROCESS OF CHANGE GLOBAL APPLICABILITY

23 AWARENESS WHAT DO WE DO AWARENESS AND INTEGRATION AVAILABLE TECHNOLOGIES LOOK OUTSIDE SPECIFIC INDUSTRY - FOOD, BIOTERRORISM, ELECTRONICS OPPORTUNITIES WITHIN THE OPERATIONS WILLINGNESS- TO BE THE FIRST INTEGRATION DEVELOP AND OVERALL STRATEGY BASED ON KNOWN AND POTENTIAL RISKS NO ONE SIZE SOLUTION ANALYTICAL ONE TEST PER PARAMETER LAYERED COMPLIMENTARY SYSTEMS /PROTECTION CUMULATIVE IMPACT - BENEFITS AND JUSTIFICATIONS ACROSS MANY SYSTEMS

24 QUESTIONS?????