Introduction to RAPID MICROBIAL METHODS. Presented By: Erin Patton, Sr. Product Specialist

Transcription

1 Introduction to RAPID MICROBIAL METHODS Presented By: Erin Patton, Sr. Product Specialist

2 DISCUSSION AGENDA 1 Impact of Rapid Methods 2 Cost Savings from Rapid Methods 3 Considerations When Choosing a Rapid Method 4 RMM Technology Selection 2 EVERY STEP OF THE WAY

3 IMPACT OF RAPID METHODS Many consider the limitations of traditional testing as antiquated technology labor-intensive methodology low test sensitivity, especially to stressed or slow-growing organisms long time-to-result and look to rapid microbial methods as a solution to these problems. 3 EVERY STEP OF THE WAY

4 IMPACT OF RAPID METHODS The true benefit of RMMs are realized across multiple departments. Manufacturing Operations Significant cost and process efficiencies across the manufacturing cycle, as well as improved quality outcomes. Warehouse Operations Less product kept in quarantine awaiting release, better market response time. 4 EVERY STEP OF THE WAY

5 WHAT RAPID MEANS TO YOU The Cost Savings from RMMs Reduced cost of manufacturing Reduced inventories Earlier response to contamination events Financial savings from a leaner manufacturing cycle

6 cost VIEW FROM THE QUALITY DEPARTMENT The Cost Savings from RMMs Q C D E P A R T M E N T D I R E C T C O S T Increased costs in QC Department include reagents and consumables Traditional method Rapid Method 6 EVERY STEP OF THE WAY

7 cost HIDDEN COSTS ADD TO TRUE COST PER TEST The Cost Savings from RMMs C O N T A M I N A T I O N R E C O V E R Y W A R E H O U S E S P A C E C O S T S SAVINGS PER TEST I N V E S T M E N T I N S A F E T Y S T O C K I N V E S T M E N T I N F I N I S H E D G O O D S Q C D E P A R T M E N T D I R E C T C O S T Increased costs in QC Department include reagents and consumables Traditional method Rapid Method 7 EVERY STEP OF THE WAY

8 REDUCING INVENTORY AND LEAD TIMES The Cost Savings from RMMs 8 EVERY STEP OF THE WAY

9 REDUCING INVENTORY AND LEAD TIMES The Cost Savings from RMMs 9 EVERY STEP OF THE WAY

10 THE COST SAVINGS FROM RAPID DETECTION Enhanced Risk Management The benefits of Celsis technology double when the issue of time and responsiveness is most critical

11 FINANCIAL IMPACT ASSESSMENT The Cost Savings from RMMs Using readily available financial and QC data, the following can be determined: Net Present Value over 5 years Payback Period Calculation Annual Containment Savings Calculates single and multi-site implementations Business Specific Input Calculated Results Begin first period Jun-15 Five-year Net Present Value ($,, ) 1,215,591 Cost of Capital 10.0% Payback Period (Months) 7.88 Stock carrying cost 20.0% Annualized Containment Savings ($,, ) 100,000 Value of Daily Finished Goods Output ($,, ) 100,000 Space needed for daily output (Sq.Unit.) 1,500 Risk Management of Contamination Events Warehouse space cost ($,, )/Sq Unit/Annum) Frequency (Occur./Yr) 0.50 Lab technician salary & benefits ($,, ) 60,000 Loss Factor 50% Current days to detection 5 Testing Proposed days to detection 1 Validation tests per product 25 Number of products for validation 20 Include Safety Stock Savings? Number of tests per year 5,000 Enter Yes or No yes Quarantine days -Current 5 Quarantine days -Celsis 1 Implementation by Period Current test cost 4.00 Period % Celsis test cost 7.75 Period % Period % Fixed Transfer Costs Period % Equipment purchase 97,657 Validation Support 11 EVERY STEP OF THE WAY

12 PRIMARY CONSIDERATIONS WHEN CHOOSING AN RMM How the world s leading pharmaceutical and personal care product companies choose a method 01. Testing Requirements 02. Range of Product Application 03. Time to Result 04. Non-Destructivity 05. Throughput 06. Knowledge and Experience of Supplier 12 EVERY STEP OF THE WAY

13 CONSIDERATION #1: TESTING REQUIREMENTS Primary Considerations When Choosing a Rapid Method Ability to process samples efficiently with minimal input personnel labor additional equipment space requirements Ease of use to ensure implementation success System complexity and need for maintenance Accuracy and sensitivity of results Objective, not subjective readout Minimal potential for user error 13 EVERY STEP OF THE WAY

14 CONSIDERATION #2: RANGE OF APPLICATION Primary Considerations When Choosing a Rapid Method Ability to process samples from various sources Incoming raw materials In-process manufacturing checkpoints Finished product bulk Finished product in final container Ability to process samples of various volumes Ability to process samples with different product attributes 14 EVERY STEP OF THE WAY

15 CONSIDERATION #2: RANGE OF APPLICATION Product and sample attribute variability Product/Sample Variability W/ or w/o filtration Varying broth volumes/types Soluble / Non-soluble products High ph / Low ph products Oil / Water based products Pigmented products Preserved products Product Matrix Examples IV Solutions, Antibiotics, Vaccines Tablets, Syrups, Suspensions Lotions, Creams, Ointments, Gels Medical Devices, Packaging Soaps, Detergents, Fabric Softeners Toothpaste, Deodorant, Cosmetics Ink, Pudding, Juices, Nutritionals 15 EVERY STEP OF THE WAY

16 CONSIDERATION #3: TIME TO RESULT Primary Considerations When Choosing a Rapid Method An ideal RMM should strike a balance between: total elapsed test time hands-on technician time to perform assay time required for other tests to be complete (e.g. potency testing from chemistry lab) But, critically, the time reduction to overall manufacturing cycle should be considered 16 EVERY STEP OF THE WAY

17 CONSIDERATION #3: TIME TO RESULT Primary Considerations When Choosing a Rapid Method 17 EVERY STEP OF THE WAY

18 CONSIDERATION #4: NON-DESTRUCTIVITY Primary Considerations When Choosing a Rapid Method Destruction of sample can lead to the need to repeat tests Undermines the reliability and trustworthiness of your method Can result in additional time and cost Potentially problematic for investigations if assayed sample is no longer available to assay for species of contaminating microbe 18 EVERY STEP OF THE WAY

19 CONSIDERATION #5: THROUGHPUT Primary Considerations When Choosing a Rapid Method Traditional testing is not technologically sophisticated, but with most methodologies (either MLT or sterility), dozens or even hundreds of samples can be tested per day RMM should be able to support adequate sample throughput and guard against necessity of extra resources or RMM setups or modules Most rapid systems allow for higher volumes than the traditional method. In environments with considerable volumes of raw ingredients, in-process batches, and final products to test, a high throughput can confer an important advantage for maintaining manufacturing uptime and moving inventory as quickly as possible. Tim Sandle, Approaching the Selection of Rapid Microbiological Methods, IVT Network Blog, EVERY STEP OF THE WAY

20 CONSIDERATION #6: KNOWLEDGE & EXPERIENCE OF SUPPLIER Choosing the right rapid method means having choosing a supplier who offers outstanding support. Questions to consider: What is the provider s experience with testing similar products or materials in my industry? Is the technology mature? What kind of technical support services are offered? What validation support is available? Does the provider have experience with regulatory compliance? Is the system known to regulators? Primary Considerations When Choosing a Rapid Method Have other implementations been successful? 20 EVERY STEP OF THE WAY

21 RMM TECHNOLOGY SELECTION Growth Based Methods: Detectable signal is achieved after a period of growth Amplified ATP Bioluminescence CO2 Production Flow Cytometry Fluorescence-Assisted Colony Counter Standard ATP Bioluminescence Digital Imaging Technology Direct Measurement: Individual cells are differentiated and visualized Flow Cytometry Solid Phase cytometry 21 EVERY STEP OF THE WAY

22 RMM TECHNOLOGY SELECTION TECHNOLOGY PRODUCT APPLICATION TIME TO RESULT THROUGHPUT VIABILITY ADOPTION Amplified ATP Bioluminescence Broad (Celsis) h High Non-destructive 800 Global Instruments CO 2 Production Broad h Low Non-destructive Limited Clinical Solid & Flow Cytometry Limited 9-50 h Low Destructive Limited Fluorescence Limited h Low Non-destructive Limited ATP Bioluminescence Limited (filter) h Low Non-destructive Limited 22 EVERY STEP OF THE WAY

23 CHOOSING A RAPID METHOD An exercise in prioritization and cross-functional teamwork When selecting a Rapid Micro Method, there are many considerations and limitations to keep in mind Considerations of the product to be tested Considerations of the lab in which the testing will happen personnel experience, lab space, throughput needs Considerations about the technologies and vendors of various RMMs Central concern should be in regards to the improvement that is offered to the company as a whole, which may not always be directly in line with desired improvements for the QC lab in particular! For example, some RMMs offer increased automation of process, but not necessarily the financial benefit of reducing overall manufacturing cost 23 EVERY STEP OF THE WAY

24 IN SUMMARY Why rapid? RMMs are often considered to offset the limitations of traditional testing antiquated technology labor-intensive methodology low test sensitivity, especially to stressed or slow-growing organisms long time-to-result But, in fact, their true benefit lies in the improvements they offer to the overall manufacturing cycle and its inherent high risk and cost! 24 EVERY STEP OF THE WAY

25 CONTACT US Erin Patton, Sr. Product Specialist Address: 251 Ballardvale Street Wilmington, MA Website: Phone: 877.CRIVER.1