Hong Kong Sterile Packaging Process & Packaging materials THE BACTERIAL BARRIER FOR HUMAN PROTECTION

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Egbert Bryant
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1 Hong Kong 2016 Sterile Packaging Process & Packaging materials THE BACTERIAL BARRIER FOR HUMAN PROTECTION

2 Packaging material evolution Evolution axes of CSSD practice in Europe Technical progress Better knowledge of material performance Mechanical resistance Microbial Barrier Standards for packaging ISO and EN 868 series Cost saving 2

requirements for forming, sealing and assembly processes In CSSD life, major impacts result from ISO 11607-2 and how to apply this standard Responsibility for the CSSD to

3 Packaging material selection and standards What is the impact of standards changes in European practices? Last change : 2006 / EN ISO & 2 replace EN standard Part 1 : Requirements for materials, sterile barrier systems and packaging systems Part 2 : Validation requirements for forming, sealing and assembly processes In CSSD life, major impacts result from ISO and how to apply this standard Responsibility for the CSSD to follow a validation process/rational Producer of sterile barrier system to give support and guaranty (guideline, IFU, ) regarding the material used in the CSSD. An example : for paper/film pouches Control of sealing Seal check procedure 3

4 ISO : Validation of the process Responsibility for the CSSD to follow a validation process with a rational Necessity of a quality document (validation plan) describing (at least) Responsibilities (person responsible for validation and operator) Type of material, its characteristics,. supplier data Type of sterilization Type of Medical Device to be sterilized Folding & packing protocol Acceptation criteria Qualification step Validation approval Design Qualification (DQ) 4

5 ISO : Validation of the process Responsibility for the CSSD to follow a validation process with a rational Necessity of a quality document describing (at least) Responsibilities (person responsible for validation and operator) Type of material, its characteristics,. supplier data Type of sterilization Type of Medical Device to be sterilized Folding & packing protocol Acceptation criteria Qualification step? 5

ISO 11607-2 : Validation of the process Qualification in 3 steps : Installation Qualification (IQ) Process of obtaining and documenting evidence that equipment has been provided and installed in

6 ISO : Validation of the process Qualification in 3 steps : Installation Qualification (IQ) Process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification No equipment but we can consider : Product specification Training of operators Work Area - Table surface smoothness - Table surface cleanliness - Table with appropriate dimension - Appropriate light 6

7 ISO : Validation of the process Qualification in 3 steps : Operational Qualification (OQ) Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures To define the worst case scenario - Maximum Tray Size, heavy load for each type of material - Transport To apply the wrapping guidance Check & validation that the packing is appropriate following acceptance criteria - Pack integrity - No openings or gaps - No punctures or tears - Unwrapping with aseptic presentation of the contents. 7

8 ISO : Validation of the process Qualification in 3 steps : Performance Qualification (PQ) Process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification Check repeatability and reproducibility of the process Control plan & frequency? - 100% of the pack are checked after sterilization and before opening in OR Follow up of the non conformance 8

9 ISO : Validation of the process ISO/TS 16775:2014 A guideline for ISO & -2 Packaging for terminally sterilized medical devices Guidance on the application of ISO and ISO

10 ISO : Validation of the process ISO/TS 16775:2014 A guideline for ISO & -2 10

11 ISO : Validation of the process For wrapping material, visual inspection at each step is required If material is conform to ISO and EN 868 AND if not damaged => assumption to have the sterility For pouch, validation of the sealer is required Development of blue ink test For container, visual inspection development of leak test 11

12 Container validation : leak test New validation protocol developed in France by CSSD managers Test protocol to perform on reusable sterile barrier systems (containers) in order to evaluate the impermeability of the vat/lid closure FD S July 2014 French document equivalent to Technical Report (strickly informative) 2 publications on this topic during last WFHSS congress Freddy Cavin lecture (CHU Lausanne) Poster CHI Aulnay sous bois 12

13 Container validation : leak test Test protocol 13

14 Container validation : leak test Results of study (Lausanne Hospital) 4 CSSD tested CSSD # Controled container # Non-conformance A B C 20 8 D Actions done : All the non conform containers have been sent for maintenance Some of them have been discarded, or the lid has been replaced. Recommendation Routine check of the container by this protocol Use of inner wrap 14

15 Container validation : leak test Validated by recent studies : 2006 Dunkelberg - American Journal of Infection Control Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections 2015 Schaffer & All - American Journal of Infection Control - Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress 15

16 Protective packaging A lot of costumer require a better protection for wrapping material Development of specific protective packaging SMS high grammage without bacterial barrier / low cost Tray system Titepack system 16

17 Protective tray ArjoTray Stackable sterilizable transportation tray to protect the Sterile Barrier System. A tray with 1000 cycles warranty allowing safe transportation of heavy trays

Titepack new concept to protect the pack Reinforce and give maximum protection to your Sterile Barrier System Self-bonded film using the shrink principle and the heat in the sterilizer Allow a

18 Titepack new concept to protect the pack Reinforce and give maximum protection to your Sterile Barrier System Self-bonded film using the shrink principle and the heat in the sterilizer Allow a perfect peeling at the point of use No accidental opening related to tape Compatible with all types of Steam sterilization cycles Compatible with all types of sterilization wraps Compatible with all ISO tray sizes width and length 18

19 BEFORE STERILIZATION Step 3 AFTER STERILIZATION Step 1: CUT Step 4: CHECK Step 2: SLIDE STEAM STERILIZATION CYCLE Step 5: OPEN

20 A new trend : Automatisation in the CSSD Lille hospital with turtles - Helsinki hospital with robots 20

A new trend : Electronical BD test Today we can do

will give more reliable & accurate measurements

Electronic sterilization controllers give more

21 A new trend : Electronical BD test Today we can do far better than yesterday, as electronic device will give more reliable & accurate measurements than thermic inks. Electronic sterilization controllers give more accurate data information such as : Temperature/Time/Pressure probe Electronical Bowie & Dick 21

22 What s the Bowie & Dick Objective? Bowie-Dick (BD) test allows to check: Air leaks ( allow to check good insulation of equipment) Efficiency of Air removal during the vacuum phase That No NCG ( Non Condensable Gaz) are present in the steam Should be used for vacuum-assisted steam sterilizers As described in The norms EN 554 (replaced by EN ISO 17665) & in good practices, it requires performing a BD test every morning before the processed load in an empty chamber

23 Electronic Bowie & Dick : how does it work? SAS : Steam Air Separator Electronic and battery compartment Glass balls Internal temperature probe External temperature probe

24 Electronic Bowie & Dick : Advantages Calculated Result (temperature difference + algorithm) with easy reading PASS or FAIL No need to be interpretate by operators Reproducibility results

25 Thank you for your attention! THE BACTERIAL BARRIER FOR HUMAN PROTECTION

Meeting the challenges of medical device packaging

Meeting the challenges of medical device packaging Gisela Cristina Mendes Bastos Viegas, S.A. October 14, 2011 Agenda Evaluation and selection Validation Test methods Sterile Barrier Systems EN 868 Parts