Robust Microbial Protection Amidst Increasing Regulatory Challenge

Transcription

1 Industrial Pharma&Biotech MicrobialControl Solutions 2015 Lonza Robust Microbial Protection Amidst Increasing Regulatory Challenge ASEFAPI 5 th November 2015 Phil Clegg, Lonza (Europe, Middle East and Africa)

2 Disclaimer The information contained herein is believed to be correct and corresponds to the latest state of scientific and technical knowledge. However, no warranty is made, either expressed or implied, regarding its accuracy or the results to be obtained from the use of such information and no warranty is expressed or implied concerning the use of these products. The buyer assumes all risks of use and/or handling. No statement is intended or should be construed as recommendation to infringe any existing patent. Some products may not be available in all markets or for every type of application. Any user must make his own determination and satisfy himself that the products supplied by Lonza Group Ltd and the information and recommendations given by Lonza Group Ltd are [i] suitable for intended process or purpose, [ii] in compliance with environmental, health and safety regulations, and [iii] will not infringe any third party s intellectual property rights. 2

3 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 3

4 Lonza Group Ltd. Trusted supplier to the pharmaceutical, biotech and specialty ingredients markets Founded in 1897 with headquarters now in Basel, Switzerland Lonza Target Markets Pharma&Biotech Consumer Care Agro Ingredients Industrial Solutions Wood Protection Water Treatment Offerings: API Manufacturing Services CMO API Development Services CDO Products & Consumables for Research & Production Offerings: Personal Care: Active Ingredients, Functionals & Preservatives Nutritional Ingredients (Vitamin B3) Hygiene: Antimicrobial Products Offerings: Custom Manufacturing Services Fertilizers & Molluscicides Formulation Solutions for Crop Protection (Biocides) Offerings: Biocides & Preservatives for Materials Protection High-Performance Materials for Electronics & Composite Industry Cracker (Verbund) Corrosion Inhibitors & Specialty Chemicals for Oil & Gas Applications Offerings: Industrial Preservatives & Fire Retardants for Pretreatment & Surface Protection of Wood Wood Building- Material Brand Offerings: Sanitizers & Other Treatment Chemicals for Pools & Spas Feeder Systems for Drinking Water Agricultural & Industrial Water Treatment 4

5 Global Footprint Headquarters in Basel, Switzerland Employs ~9,800 people 5

6 Market Segments Lonza Pharma & Biotech Market Segment Chemical and biotech manufacturing expertise & technologies Drug development services Research & testing solutions for pharma & biotech markets Specialty Ingredients Market Segment Water treatment systems including sanitizers and feeder systems Agro chemical custom manufacturing Nutritional ingredients Wood treatment Hygiene & preservation solutions Personal care products Industrial solutions 6

7 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 7

8 CLP Regulation CLP Regulation The European Union has now implemented the United Nations' GHS (Globally Harmonized System of Classification and Labelling of Chemicals) into EU law as the CLP Regulation Introduced GHS concept of sub-categories for respiratory and skin sensitizers Category 1A High potency Category 1B Moderate-Low potency Revised EU specific limits for elicitation labelling Labelling as EUH208 Allergen phrase EUH208 is designed to protect the population already sensitized to a substance where exposure to low levels may cause an allergic reaction Implications of EUH208 Unique requirement to the EU Some formulations, which would otherwise be non-hazardous, will attract this labelling 8

9 Implications of New Labelling Criteria Biocide Active Assumed Labelling Limit for H317 PHMB 1B 1% 0.1% IPBC 1(B) 1% 0.1% Labelling Limit for Allergen Phrase EUH208 MIT 1A 0.06% 0.006% assumed BBIT 1A 0.1% 0.01% assumed Formaldehyde 1 0.2% 0.02% assumed Triazine* 1A 0.1% 0.01% OIT 1A 0.05% 0.005% 50 ppm BIT 1A 0.05% 0.005% 50 ppm CMIT/MIT 1A % % 1.5 ppm H317: May cause an allergic skin reaction Categories in red are current estimates 9

10 Implications for In-Can Preservation Example 1: 2-chloro-5-methyl-isothiazolinone/methyl-isothiazolinone (CMIT/MIT); no H317 skin sensitization label at <15 ppm Typical use level: Now will trigger a EUH208 Contains 2-chloro-5- methyl-isothiazolinone/methyl-isothiazolinone. May produce an allergic reaction, if the use level is >1.5 ppm Example 2: 1,2-benzisothiazolin-3-one (BIT) ; no H317 skin sensitization label at <500 ppm Typical use level: ppm; Now will trigger a EUH208 Contains 1,2-Benzisothiazolin-3-one. May produce an allergic reaction, if the use level is >50 ppm 10

11 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 11

12 Role of Biocides Long term dry-film preservation BIOCIDES Long term in-can preservation Short term liquid treatment (disinfection) Decontamination of tanks and other equipment Process water treatment

13 What Market Requirements for In-Can Preservatives Need to Be Fulfilled? Need Robust Preservation Broad spectrum activity Compatibility with formulation Temperature/pH stability The Formulator s Challenge Need to Meet European Market Requirements Formaldehyde free CMIT/MIT free MIT free Cost effective Zero VOC Regulatory approvals Hazard label free product 13

14 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 14

15 Looking Ahead Pyrithione as a complementary biocidal active substance Favourable Indicators Regulatory support in all key regions Non-isothiazolinone does not attract H317 or EUH208 label warnings Non-volatile and water soluble (sodium salt) Good ph and thermal stability Broad spectrum mechanism, complimentary to BIT mechanism Precautions Good compatibility with most preserved product ingredients, but potential for pyrithione reaction with ferric ion impurities Several Lonza proprietary technologies have been developed to suppress this reaction 15

16 Looking Ahead What is the profile for a robust in-can preservative? Isothiazolines are efficient preservatives favourable cost/effect Isothiazoline base + sufficient other active = robust preservation Example pre-2015 CLP; 15 ppm CMIT/MIT ppm BIT Post 2015 CLP, 1.5 ppm CMIT/MIT is insufficient for isothiazoline base Use BIT as the isothiazoline base + non-isothiazoline other active At maximum blend dosage <50 ppm BIT +? ppm other active Selection of other active Many non-isothiazoline preservatives have alkaline stability limitations Many cationic preservatives are incompatible with anionic surfactants Role for pyrithiones Determination of required pyrithione concentration 16

17 Looking Ahead Pyrithione as complimentary biocidal active substance mechanism considerations Pyrithiones act on microbial membranes acting as a chelate and disrupting important ion gradients and are not destroyed during this process but are recycled. Bacteria use these gradients to store energy, and fungi as a source of energy for nutrient transport. BIT is electrophilically active reacting with microbial enzymes containing thiol groups so disrupting a number of metabolic (energy) processes. BIT + Pyrithione = Enhanced activity Pyrithione facilitates the activity of BIT These two actives have complimentary mechanisms 17

18 A New Novel In-can Biocide BIT in combination with sodium pyrithione Colour stabilised formulation Avoids EUH208 allergen phrase at typical use level of 0.25% (below 50ppm BIT) Water soluble Low viscosity, easily pumpable Free from heavy metals MIT free CMIT free Formaldehyde and formaldehyde releaser free Demonstrated to be effective in preserved products with differing degrees of microbial susceptibility NaPT / BIT 18

19 Results for Sodium Pyrithione Combined with BIT Evaluate the selected BIT/Sodium Pyrithione ratio to determine if the dosage range ( %) will cover the susceptibility range of common preserved products. In an industry standard antimicrobial challenge test, 0.25% (or less) of preservative effectively preserved all of the following materials; Material ph Challenge Type Untreated Control Blend Pass Level Acrylic polymer emulsion 8.0 Bacterial Spoiled 0.10% Urethane emulsion 7.4 Bacterial Spoiled 0.25% Neutral ph polymer emulsion 6.8 Bacterial Spoiled 0.10% Acidic polymer emulsion 4.5 Fungal Spoiled 0.10% Urethane emulsion 6.8 Bacterial Spoiled 0.10% Neutral ph polymer emulsion 7.2 Bacterial Spoiled 0.15% Acidic polymer emulsion 4.3 Bacterial Spoiled 0.15% 19

20 BIT with Zinc Pyrithione for Wet-state Preservation BIT in combination with zinc pyrithione Colour stabilised formulation Avoids EUH208 allergen phrase at typical use level of 0.09% MIT free CMIT free Formaldehyde and formaldehyde releaser free Demonstrated to be effective in preserved products with differing degrees of microbial susceptibility Can be used in certain food contact applications Compatible with several eco-labels 20

21 Results for Zinc Pyrithione Combined with BIT Material ph Challenge Type Untreated Control First Challenge Second Challenge Third Challenge Styrene acrylate paint 8.2 Bacterial Spoiled Passes Passes Passes Latex matt paint 9.2 Bacterial Spoiled Passes Passes Passes Carboxylated styrene/butadiene copolymer latex Vinyl acetate polymer emulsion Styrene acrylate polymer emulsion 7.1 Bacterial Spoiled Passes Passes Passes 4.8 Fungal Spoiled Passes Passes Passes 8.7 Bacterial Spoiled Passes Passes Passes Rosin based adhesive 8.3 Bacterial Spoiled Passes Passes Passes Paraffin wax emulsion 8.9 Bacterial Spoiled Passes Passes Passes Calcium carbonate slurry In an industry standard antimicrobial challenge test, evaluated in preserved products with differing microbial susceptibility Evaluated at a fixed dosage of 0.09% of biocide. 9.4 Bacterial Spoiled Passes Passes Passes 21

22 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 22

23 Challenges Faced by a Coatings Formulator Demand for broad spectrum protection of the paint film Interior Wide variety of fungi Concern about indoor air quality; airborne fungal spores Exterior Wide variety of fungi Defacement by algae 23

24 Challenges Faced by a Coatings Formulator Biocide compatibility with the paint formulation Paint film protection agents must be chemically stable & not affect paint application deliver long lasting compatible with paints (viscosity, drying etc.) film protection 24

25 Challenges Faced by a Coatings Formulator Limited number of available biocide active agents Fungicidal Algaecidal Fungicidal/Algaecidal Octyl Isothiazolinone (OIT) Diuron Zinc Pyrithione Dichloro Octyl Isothiazolinone (DCOIT) N-butyl Benzisothiazolin (BBIT) Irgarol Terbutryn Iodo Propynyl Butylcarbamate (IPBC) Chlorothalonil (CTL) Carbendazim (BCM) 25

26 Challenges Faced by a Coatings Formulator Active agents have different water solubility and different microbial spectrum Group A Low Water Solubility Biocide Active Agents Grouped by Water Solubility Group B Medium Water Solubility Group C High Water Solubility Zinc Pyrithione g/l Diuron g/l Octyl Isothiazolinone (OIT) 0.48 g/l Chlorothalonil (CTL) g/l DCOIT g/l N-butyl Benzisothiazolin (BBIT) 0.7 g/l Carbendazim (BCM) g/l Terbutryn g/l Iodo Propynyl Butylcarbamate (IPBC) g/l Irgarol g/l 26

27 Challenges Faced by a Coatings Formulator Why is water solubility important? In the conventional model of a paint film there is a reservoir of fungicide active agent in the paint film, and there is also some fungicide on the surface of the paint. As rain falls on the surface of the paint film, it washes away the fungicide on the surface, however the fungicide at the surface of the film is replenished by new fungicide that is drawn from the reservoir in the paint film. If the fungicide has too high a water solubility, then the reservoir will be depleted and the coating will show defacement O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O O No growth No growth No growth Heavy growth 27

28 Zinc Pyrithione Zinc pyrithione Provides durable dry film protection against both fungi and algae Advantages of zinc pyrithione Biocide formulation optimized for use in coatings Lonza s zinc pyrithione formulations has good compatibility history with other paint ingredients This formulation contains proprietary Lonza technology to suppress zinc pyrithione trans-chelation Broad range of ph stability Excellent thermal stability Zero VOC Can be used for both interior and exterior paints Interior paints are increasingly being rated for mould resistance Zinc pyrithione is familiar to consumers as the world s leading anti-dandruff agent Supported by Lonza for several industrial applications. 28

29 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 29

30 Technical Support Microbiological Evaluation / Enumeration Microbial Identification Microbial Challenge Tests Biocide optimisation study Microbial recovery test Plant Hygiene Survey Biocide Analysis Biocide stability tests 30

31 Plant Hygiene Ensure production of a consistent product Minimise cost and disruption caused by product that can t be despatched or is returned Aid the performance of the added biocides in controlling bacterial contamination Discuss and observe plant design and housekeeping Take samples throughout process Microbiological evaluation Counts, streaks, identification Chemical analysis 31

32 Overview Introduction to Lonza The GHS and New CLP Regulation Biocides and The Formulator s Challenge Innovative In-can Biocide Systems Dry-film Solutions Lonza Technical Service Conclusions 32

33 Conclusions New labelling requirements pose a challenge for formulators, in that the presence of certain in-can preservative active agents might attract an EUH208 allergen phrase to formulations that would otherwise be considered as non-hazardous. Lonza s innovative in-can biocide systems have been shown to provide robust in-can preservation in many applications without the requirement to declare a EUH208 phrase on the packaging. The active substances in these blends are supported by Lonza through the BPR and listed / approved for many applications. Zinc Pyrithione is a broad spectrum dry-film biocide, effective against fungi and algae. 33

34 Conclusions Support from Lonza Strong global regulatory and toxicology expertise and support Strong microbiological and analytical chemistry support Innovation Center in Alpharetta, Georgia On-going exploration of leading edge technologies Strong corporate focus on Material Protection and Industrial Solutions Development of products that are consistent with current requirements but are also aligned with trends and anticipated future market needs 34

35 Thank You! All trademarks belong to Lonza or its affiliates or to their respective third party owners and are used here only for informational purposes. Use Biocides Safely. Always read the label and product information before use