Biography. Cleaning & Disinfection. Overview of Veltek Associates, Inc. Peter Koger Veltek Associates Inc.

Transcription

1 Cleaning & Disinfection Peter Koger Veltek minute session 1 Biography Peter Koger has been active in the life science industry for over 30 years. First 12 years working in different laboratories in microbiology and the remainder working for various international organizations, active in the life science/pharmaceutical industry. For about 12 years Peter has been a technical resource to the pharmaceutical industry in relation to viable monitoring and cleaning&disinfection. Since 2002 he is a frequent industry speaker and since 2004 a faculty member and trainer with the PDA in Europe Since 2005 Peter is working with Veltek, a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focused on the Pharmaceutical industry. His role is that of a Technical Sales Manager responsible for Europe and Asia. 2 INNOVATION Innovation solicits creation. Creation summons thought. Thought relies on inspiration. Inspiration promotes action. Action invites movement. Movement warrants relocation. Relocation creates unfamiliarity. Unfamiliarity forces learning. Learning returns us to innovation. 3 1

2 1981 Founded by Art Vellutato, Sr. Began production of disposable garments in a clean room from beginning to end to assure the cleanliness of the final product Designed the SMA the first microbial air sampler that could be completely sterilized Developed DECON-AHOL the first 0.2 micron filtered alcohol that was irradiated in a nonaspirating aerosol spray container 6 2

3 1993 Began a complete line of sterile chemicals, disinfectants and sporicides that are filtered at 0.2 microns Introduced the first 0.2 micron filtered and sterilized clean room lubricants 8 SCMD - Sterile Chemical Manufacturing Division DEC-AHOL WFI STER-AHOL WFI ALCOH-WIPE ALCOH-GLOVE DEC-HAND DEC-PHENE DEC-PHASE DEC-CYCLE PHENE-AHOL DEC-Clean DEC-QUAT 100 HYPO-CHLOR STERI-PEROX DEC-SPORE 200 Plus STERI-WATER VAI WFI Quality Water STERI-BUFFER STERI-OIL 200 STERI-SILICON STEEL-BRIGHT DAS-WIPE DEC-GLASS SimpleMIX Process2Clean Cage2Wash 9 3

4 1997 Designed and manufactured sterile ingredients for use in parenteral manufacturing Introduced the first computerized microbial air sampling system Developed the Core2Clean. A fully autoclavable system that allows for excellent cleaning&disinfection in 50% of the time needed with mop&bucket Developed the SimpleMIX System - a multi-chamber system designed to eliminate filter sterilizing of disinfectants and sporicides Moved into a new state-of-the-art, 240,000 square foot, FDA and EPA registered facility in Malvern, PA 12 4

5 2007 Introduction of the new Process2Clean and Cage2Wash product lines. Developed to help improve and ease the process of clean-in-place applications and animal cage washing facilities DDC Digital Control Center with digital flow control on each sample point DRY-WIPES sterile 12 x 12 dry wipes SPORICIDAL-WIPE saturated wipe Saturated disinfectant and sporicidal wipes 2011 Saturated neutral detergtent Wipe New hands free IPA or hand sanitizer dispenser 15 5

6 2012 Sterile Aerosol WFI 2013 Aerosol Disinfectants Easy2Write Sterile Indistructable Paper Easy2Print Sterile Cleanroom Printer SMA OneTouch ICS The capabilities of a single SMA OneTouch ICS replaces ALL of our previous generation of equipment COMBINED Divisions SCMD - Sterile Chemical Manufacturing Division ECMD - Environmental Control Monitoring Division DPMD - Disposable Products Manufacturing Division VLTD - VAI Labs Testing Division 1 Affiliate API - Aseptic Processing, Inc. a consulting firm for the pharmaceutical and biotechnology industries 18 6

7 The total is more than the sum of its parts Process (formulation, filtration, filling, sealing) People (gowning, movements, limited access, training) Facility (layout, design, pressurization, HEPA, maintenance, temp., humidity, water/drain) Sanitization (cleaning/disinfecting agents, environmental monitoring) 19 Controlling What Enters the Environment 20 Requirements for a cleaning and disinfecting program Written procedures describing in sufficient detail the cleaning and disinfection procedures, schedules and materials used, preventing microbiological contamination Validation of the cleaning and disinfection agents EM data serves as a basis for the selection and evaluation of the agents Procedure should include rotation, sporocidal use and cleaning exercises to address possible residues. Disinfectants and cleaning agents in Grade A/B should be sterile. 21 7

8 Choosing the right Disinfectants and Cleaners But what is the difference? Cleaning is often confused with Disinfection.. They are NOT the same 22 Cleaning the Environment

9 Cleaning versus Disinfection Cleaning Removal of Particulate and Microbes from the surface Removal of Residues and buildup that can complicate Disinfection Disinfection Saturate and Penetrate the cell wall For X time period Concern with particulate, resiudes and irregular surfaces 25 Cleaning versus Disinfection Surfaces complicate cleaning and disinfection Flat surfaces are easier to clean, but dry faster Intricate surfaces are harder to clean and dry slower The remaining residual after rinse is the question 26 Cleaning Walls, Ceilings, curtains and Floors Scrub with a mop and solution which has excellent detergency Before the surface dries, rinse the surface with water Collect the remaining liquid on the floor and wet vacuum it out of the area Allow the surface to dry and then disinfect 27 9

10 Cleaning Filling Lines and Process Equipment Scrub the surface with a wipe and a solution which has excellent detergency Before the surface dries, rinse the surface and wipe with a dry wipe, lifting the solution Allow the surface to dry and then disinfect 28 Cleaning Carts, Tanks and Tools Scrub the surface with a wipe and a solution which has excellent detergency Before the surface dries, rinse the surface and wipe with a dry wipe, lifting the solution Allow the surface to dry and then disinfect Carts and Tools should be removed, cleaned and autoclaved if possible!! 29 Why cleaning? Cleaning return the surface to its original state, which is good starting point for disinfection Cleaning addresses residues from earlier disinfection Required by regulatory 30 10

11 Residues Sodium hypo chlorite Phenol Quaternary ammonium 31 The effect of rinsing 32 Using water against residues 33 11

12 Using DecClean against residues 34 Choosing Disinfectants/Sporocide Type and number of microbes present Type of activity desired Type and amount of organic matter present Potential for corrosion or deterioration 35 Choosing Disinfectants/Sporocide The choice is mostly delineated by review of the contamination you have noticed in your facility s Environmental Isolate list, next to the required ATCC strains. The goal is broad spectrum disinfection Effect of certain disinfectants on final product (compatibility) 36 12

13 Disinfectant characteristics Chemical Gram + Gram - Spores Fungi Viruses Isopropyl Alcohol Ethanol Quaternary Ammonium Phenol High ph Phenol Low ph Hydrogen Peroxide (6% Bleach Peracetic Acid & H2O Glutar Aldehyde Disinfectant characteristics Chemical Corrosive Staining Toxic Isopropyl Alcohol NO NO NO Ethanol NO NO NO Quaternary Ammonium 1 NO NO Phenol High ph 1 NO YES Phenol Low ph 1 NO YES Hydrogen Peroxide (6%) NO NO YES Bleach 2 NO YES Peracetic Acid & H2O2 2 1 YES Glutar Aldehyde 2 1 YES 38 Isopropyl versus Ethyl alcohol 90% of all drug companies use IPA 70% kills dried organisms better than higher percentage Ethanol and IPA show little differences in killing efficiency but seem more effective on clean room organisms Both have poor detergency Sterility and continued sterility over use is critical 39 13

14 Phenols Often used in high ph/low ph rotation Good broad spectrum kill of vegetative organisms with some log reduction of spores Medium detergency Residues build up and darken with age from light High ph amber turns to dark brown, low ph is pink turns to dark purple Residue is difficult to remove and sets (IPA/cleaner) 40 Quats Good broad spectrum kill of vegetative cells Excellent detergency, they remove residues during the CLEANING operation Residues are minimal 41 Peroxides Good broad spectrum kill of vegetative cells Used in 3% and 6% Sometimes rotated with quats Some log reduction of spores No detergency Residues are non existent 42 14

15 Sodium Hypo Chlorites Used as a sporocide at 0.25% or greater Good broad spectrum kill of vegetative cells and spores Good detergency Excellent (long) dry time High residue which needs to be addressed, or corrosion will occur Oldest sporocide 43 Peracetic acid + H2O2 Used as a disinfectant (0.4%) or sporocide (5%) Good broad spectrum kill of vegetative cells and spores No detergency Vapors are exponential of H2O2 and acetic acid Average dry time Residuals are minimal if any Dries porous surfaces over time 44 Disinfectant performance Temperature Saturation and Penetration of the Cell Wall Contact time Soil load and Bioburden Concentration ph Hardness of water Surface irregularity 45 15

16 Rotation because of possible resistance USP <1072> The development of microbial resistance to antibiotics is a well-described phenomenon. The development of microbial resistance to disinfectants is less likely, as disinfectants are more powerful biocidal agents and are applied in high concentrations against low populations of micro organisms, so the selective pressure for the development of resistance is less profound. 46 Nevertheless. Rotation is still required. Possibilities are: Two disinfectants and a sporocide One disinfectant and a sporocide One agent at different concentrations 47 One Disinfectant and a Sporocide Day(s) Phenolic Quad H2O Low ph phenol Quaternary ammonium 14 (if warranted by EM) Clean, allow to dry, use sporocide Clean, allow to dry, use sporocide Low ph phenol Quaternary ammonium 30 (if warranted by EM) Clean, allow to dry, use sporocide Clean, allow to dry, use sporocide Hydrogen peroxide Clean, allow to dry, use sporocide Hydrogen peroxide Clean, allow to dry, use sporocide After disinfection, when all surfaces are dry, all critical surfaces should be rinsed with hot WFI or an IPA wipedown performed

17 Time to validate our choices The firm has not supported the use of current disinfecting agents with data proving that such disinfectants are effective in controlling contamination noticed through their environmental monitoring program 49 Use and Application More than the availability of the right detergents, disinfectants and sporocidal agents, is the quality of the surfaces that need be addressed and the way they are being applied, determining the final cleanliness of the classified area. 50 Scanning Electron Microscopic views of surfaces The surface to be disinfected 51 17

18 52 General order of Disinfection Clean the area (line clearance) Disinfect Ceilings Disinfect Walls Disinfect Equipment Disinfect floors Allow to air dry Rinse or IPA wipe down of equipment Once a month Clean and Rinse all surfaces 53 Mop Wipe Spray Fog Applying Disinfectants STRUCTURED COMBINATION OF ALL 54 18

19 When to apply disinfectants Area type Ceilings Walls Floors Curtains Critical work surface Class A/B Weekly Weekly mopping and poss. Daily spraying Daily Daily Daily Class C Weekly Weekly Daily Daily if applicable Daily Class D Monthly Monthly Weekly NA Daily 55 Wrap up. A proper cleaning and disinfecting SOP, should be based on EM data and a lot of common sense. Only if and when carried out correctly, with a good selection of the parameters (choice of chemicals and application methods) longer term success is attainable CONTROL what ENTERS!!! Train, train, train, and when you are done training... You train some more. 56 Thank you for your interest