Challenges in Preserving Wet Wipes

Transcription

1 Challenges in Preserving Wet Wipes PCPC Microbiology Workshop October 26, 2011 Douglas Cole Technical Director Rockline Industries Preserving Wet Wipes - A Delicate Balance 1

2 Personal Care Wet Wipes Products Baby Personal Care (MTT) Facial Hemorrhoidal Feminine Antibacterial / Antiseptic Sun Screen Self Tanning Health Care and I&I Sports Personal Care Wet Wipes Products Baby Personal Care (MTT) Facial Hemorrhoidal Feminine Antibacterial / Antiseptic Sun Screen Self Tanning Health Care and I&I Sports Global wet wipe sales are nearly $8mm, $2.7mm in North America 2

3 Personal Care Wet Wipes Products Baby Personal Care (MTT) Facial Hemorrhoidal Feminine Antibacterial / Antiseptic Sun Screen Self Tanning Health Care and I&I Sports Global wet wipe sales are nearly $8mm, $2.7mm in North America Within a Wal-mart SC there are >125 different wet wipes products Wet wipes are a complex system 3

4 Wet wipes are a complex system Natural or synthetic fibers or combinations Adhesive, thermal, mechanical and hydrogen bonding and combinations Wet wipes are a complex system Natural or synthetic fibers or combinations Adhesive, thermal, mechanical and hydrogen bonding and combinations Formulations including solutions, emulsions and suspensions 4

5 Wet wipes are a complex system Natural or synthetic fibers or combinations Adhesive, thermal, mechanical and hydrogen bonding and combinations Formulations including solutions, emulsions and suspensions Manufacturing Complexities Different converting processes Different folding configurations Vertical or horizontal stack orientation Various packaging formats Wet wipes are a complex system Natural or synthetic fibers or combinations Adhesive, thermal, mechanical and hydrogen bonding and combinations Formulations including solutions, emulsions and suspensions Manufacturing Complexities Different converting processes Different folding configurations Vertical or horizontal stack orientation Various packaging formats Large diameter dry substrate rolls are unwound, slit into wipe lanes, wetted with a formulation, folded, stacked or rolled, and packaged. 5

6 Challenges In Preserving Wet Wipes Wet wipes are susceptible to microbial growth and require additional preservatives and levels of preservatives not found in other liquid products. Challenges In Preserving Wet Wipes Wet wipes are susceptible to microbial growth and require additional preservatives and levels of preservatives not found in other liquid products. Contributing Factors Substrate and fiber interaction Fiber binding 6

7 Challenges In Preserving Wet Wipes Wet wipes are susceptible to microbial growth and require additional preservatives and levels of preservatives not found in other liquid products. Contributing Factors Substrate and fiber interaction Fiber binding Fluid migration Preservative migration Challenges In Preserving Wet Wipes Wet wipes are susceptible to microbial growth and require additional preservatives and levels of preservatives not found in other liquid products. Contributing Factors Substrate and fiber interaction Fiber binding Fluid migration Preservative migration Nonwoven Binders Fiber finishes 7

8 Challenges In Preserving Wet Wipes Wet wipes are susceptible to microbial growth and require additional preservatives and levels of preservatives not found in other liquid products. Contributing Factors Substrate and fiber interaction Fiber binding Fluid migration Preservative migration Nonwoven Binders Fiber finishes Other ingredients Solution ph Microbial resistance Challenges In Preserving Wet Wipes Traditional preservation for personal care may not be acceptable for wet wipe applications 8

9 Challenges In Preserving Wet Wipes Traditional preservation for personal care may not be acceptable for wet wipe applications Ionic bonding of preservatives to fibers Migration of wipe formulation through the wipes stack Challenges In Preserving Wet Wipes Traditional preservation for personal care may not be acceptable for wet wipe applications Ionic bonding of preservatives to fibers Migration of wipe formulation through the wipes stack Separation of ingredients & preservatives within a wipe and throughout the wipes stack Emulsion phase separation within the fiber structure 9

10 Challenges In Preserving Wet Wipes Traditional preservation for personal care may not be acceptable for wet wipe applications Ionic bonding of preservatives to fibers Migration of wipe formulation through the wipes stack Separation of ingredients & preservatives within a wipe and throughout the wipes stack Emulsion phase separation within the fiber structure Ingredient interactions with preservatives Maintaining expressed solution ph with different fiber and nonwoven suppliers Challenges In Preserving Wet Wipes Traditional preservation for personal care may not be acceptable for wet wipe applications Ionic bonding of preservatives to fibers Migration of wipe formulation through the wipes stack Separation of ingredients & preservatives within a wipe and throughout the wipes stack Emulsion phase separation within the fiber structure Ingredient interactions with preservatives Maintaining expressed solution ph with different fiber and nonwoven suppliers Leaching of fiber finishes into wipes formulation Inclusion of bactericides and fungicides 10

11 WET WIPE SUBSTRATES Wet Wipe Substrates Paper: A thin material produced by pressing together moist fibers, typically cellulose pulp derived from wood, cotton or grasses and drying them into flexible sheets. 11

12 Wet Wipe Substrates Paper: A thin material produced by pressing together moist fibers, typically cellulose pulp derived from wood, cotton or grasses and drying them into flexible sheets. Nonwoven: A web of fibers held together by some method other than weaving, usually by including some content of longer synthetic fibers Wet Wipe Substrates Paper: A thin material produced by pressing together moist fibers, typically cellulose pulp derived from wood, cotton or grasses and drying them into flexible sheets. Nonwoven: A web of fibers held together by some method other than weaving, usually by including some content of longer synthetic fibers Nonwoven technology is derived from a merging of woven, paper making and extrusion technologies. Lower cost substitute for woven fabrics Faster more versatile process than weaving Higher performance than paper Softer, stronger and bulkier 12

13 Methods of Nonwoven Fiber Bonding Adhesive Thermal Fusing Mechanical or Water Entanglement Hydrogen Bonding Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform 13

14 Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform Needle punch Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform Needle punch Hydroentangled wet laid and spunbond Hydroentangled wet laid 14

15 Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform Needle punch Hydroentangled wet laid and spunbond Hydroentangled wet laid Thermal bond SPC/SPS (spunbond/pulp/carded)/(spunbond/pulp/spunbond) Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform Needle punch Hydroentangled wet laid and spunbond Hydroentangled wet laid Thermal bond SPC/SPS (spunbond/pulp/carded)/(spunbond/pulp/spunbond) SMS Spunbond 15

16 Wet Wipes Substrates Airlaid Spunlace (hydroentangling) Coform Needle punch Hydroentangled wet laid and spunbond Hydroentangled wet laid Thermal bond SPC/SPS (spunbond/pulp/carded)/(spunbond/pulp/spunbond) SMS Spunbond Meltblown Carded web Wet laid paper Typical Fiber Types Wood Pulp - Airlaid, Hydorentangled Composites Softwood 1MM fibers/g (3mm in length) Hardwood 6MM fibers/g (1mm in length) Good opacity/high surface area/flat ribbon-like High anionic charge Good absorbency, poor strength Natural bioburden 16

17 Typical Fiber Types Wood Pulp - Airlaid, Hydorentangled Composites Softwood 1MM fibers/g (3mm in length) Hardwood 6MM fibers/g (1mm in length) Good opacity/high surface area/flat ribbon-like High anionic charge Good absorbency, poor strength Natural bioburden Rayon, Viscose, Tencel - Spunlace Staple length fiber made by dissolving wood pulp or bamboo pulp and extruding it through small holes 100,000 fibers/g Good absorbency and strength Moderate anionic charge Typical Fiber Types Polyester and Polypropylene - Spunlace Plastic fibers made by extruding molten polymer through small holes 100,000 fibers/g Nonionic Good Strength Poor absorbency (naturally hydrophobic) Can be made hydrophilic with topical treatments or polymer additives Moderate cost 17

18 Typical Fiber Types Polyester and Polypropylene - Spunlace Plastic fibers made by extruding molten polymer through small holes 100,000 fibers/g Nonionic Good Strength Poor absorbency (naturally hydrophobic) Can be made hydrophilic with topical treatments or polymer additives Moderate cost Bi-component fibers - Spunlace, Composites Multiple Lengths Polyester core surrounded by low melting polyethylene to facilitate thermal bonding Nonionic Expensive Typical Fibers Types Polylactic Acid (PLA) Spunlace, composites PLA is an aliphatic polyester made from polymerizing lactic acid from fermenting natural sugars from various sources (primarily corn) Splittable fibers Microfibers Nanofibers 18

19 Impact of Fiber Size Nonwoven Pore Structure Liquid Retention Ingredient and Preservative Distribution and Migration WET WIPES PACKAGING 19

20 Wet Wipes Packaging Challenges Tubs Flexible Films Canisters Wet Wipes Packaging Challenges Tubs, flexible films, canisters Continual opening (and remaining open) presents opportunity for additional bioburden 20

21 Wet Wipes Packaging Challenges Tubs, flexible films, canisters Continual opening (and remaining open) presents opportunity for additional bioburden High evaporation and dry wipes due to package material and design Wet Wipes Packaging Challenges Tubs, flexible films, canisters Continual opening (and remaining open) presents opportunity for additional bioburden High evaporation and dry wipes due to package material and design Reoccurring insult due to reach-in dispensing and cross contamination 21

22 WET WIPE FORMULATION Formulation Building Blocks Water Surface active agent(s) cleaning, wetting and emulsifying 22

23 Formulation Building Blocks Water Surface active agent(s) cleaning, wetting and emulsifying Emollient skin conditioning, hydration and lubricity Preservative(s) - Keeps product fresh and maintain shelf life Formulation Building Blocks Water Surface active agent(s) cleaning, wetting and emulsifying Emollient skin conditioning, hydration and lubricity Preservative(s) - Keeps product fresh and maintain shelf life ph modifiers product compatibility and preservative efficacy Fragrance scent, olfactory cues 23

24 Formulation Building Blocks Water Surface active agent(s) cleaning, wetting and emulsifying Emollient skin conditioning, hydration and lubricity Preservative(s) - Keeps product fresh and maintain shelf life ph modifiers product compatibility and preservative efficacy Fragrance scent, olfactory cues Active Ingredients OTC Drug Products Functional ingredients Vitamin E, Shea Butter Wet Wipe Preservation Parabens Phenoxyethanol Methylisothiazolinone Methylchloroisothiazolinone DMDM Hydantoin Imidazolidinyl Urea Benzyl Alcohol Diazolidinyl Urea Organic Acids Chlorophenisen Iodopropynyl Butylcarbamate Quaternium Bromo-2-Nitropropane-1,3-Diol Polyaminopropyl Biguanide Sodium Hydroxymethylglycinate HOCH 2 OCH 2 CH 2 OH O N N CH 2 OH O DC Steinberg, 2010 Frequency of Preservative Use, Cosm & Toil 125 (11) (Nov 2010) 24

25 Alternate Preservation Ethylhexyl glycerin Caprylyl Glycol Organic Acids Caprylohydroxamic Acid Botanical Extracts / Oils Citrus Seed Extracts Alternate Preservation Ethylhexyl glycerin Caprylyl Glycol Organic Acids Caprylohydroxamic Acid Botanical Extracts / Oils Citrus Seed Extracts Opportunities for Wet Wipes Green carbon preservatives Preservative-Free claim Chemical Preservative Free claim Self preservation 25

26 Alternate Preservation Ethylhexyl glycerin Caprylyl Glycol Organic Acids Caprylohydroxamic Acid Botanical Extracts / Oils Citrus Seed Extracts Opportunities for Wet Wipes Green carbon preservatives Preservative-Free claim Chemical Preservative Free claim Self preservation Activity and Capacity Limited kill rate and capacity Limited robustness Substrate and formulation limited May not work in wipes containing natural fibers Wet Wipe Preservation Antibacterial Wipes Quaternary ammonium salts Active ingredient Supplemental fungicide 26

27 Wet Wipe Preservation Antibacterial Wipes Quaternary ammonium salts Active ingredient Supplemental fungicide Water Activated Wipes Low moisture High surfactant levels High solid levels Wet Wipe Preservation Antibacterial Wipes Quaternary ammonium salts Active ingredient Supplemental fungicide Water Activated Wipes Low moisture High surfactant levels High solid levels Low Water Activity (A w ) High solvent levels 27

28 Formulation Challenges Wet Wipes Preservation Natural Bioburden Fibers and nonwoven Process water Raw material storage and handling Ingredients Packaging Equipment Manufacturing environment Personnel Formulation Challenges Wet Wipes Preservation Natural Bioburden Fibers and nonwoven Process water Raw material storage and handling Ingredients Packaging Equipment Manufacturing environment Personnel Binding/neutralization of preservatives by natural fibers 28

29 Formulation Challenges Wet Wipes Preservation Natural Bioburden Fibers and nonwoven Process water Raw material storage and handling Ingredients Packaging Equipment Manufacturing environment Personnel Binding/neutralization of preservatives by natural fibers Overwhelming product preservatives during manufacturing process Formulation Challenges Wet Wipes Preservation Natural Bioburden Fibers and nonwoven Process water Raw material storage and handling Ingredients Packaging Equipment Manufacturing environment Personnel Binding/neutralization of preservatives by natural fibers Overwhelming product preservatives during manufacturing process Package and storage conditions optimal for micro growth 29

30 Wet Wipes Testing Finished product preservative challenge testing is conducted using Personal Care Products Council (PCPC) M-5 Method coupled with PCPC guidelines for Determination of Preservation Efficacy in Nonwoven Substrate Personal Care Products. Product Stability is conducted internally using IFSCC Monograph, Number 2, Fundamentals of Stability Testing and ICH Guidelines Q1A (R2) Stability Testing of New Drug Substances and Products, Nov Guidelines on Stability Testing of Cosmetic Products, COLIPA, March Applicable Safety Testing Applicable Risk Assessment PRODUCT TESTING TIMELINE Stability (L-T) PC & Aesthetic prescribed intervals (6, 9,12,18 months) Preservative Challenge Test Dermal, Other Safety Testing Stability (Accel) Preservative Challenge (Accel./ L-T) Preservative Assay Safety Assessment (EU / UK) Weeks 20 Note: Testing begins once the finished product spec is frozen. 30

31 PRESERVATIVE CHALLENGE TESTING PRESERVATIVE CHALLENGE TESTING M-5 Method coupled with PCPC guidelines for Determination of Preservation Efficacy in Nonwoven Substrate Personal Care Products. Typical Inoculation on wipes Bacteria E. coli B. cepacia S. aureus P. Aeruginosa Sponsor Isolate Yeast C. albicans Mould A. niger 31

32 Preservative Challenge Testing Water, Glycerin, Polysorbate 20, Disodium Cocoamphodiacetate, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Chamomilla Recutita (Matricaria) Flower Extract, Disodium EDTA, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Citric Acid Baby Wipes Solution, on Spunlace, 3 0 C 0 Hours 24 Hrs. 72 Hrs. 1 Week* 2 Week Bacteria 2,100,000 <10 <10 <10 <10 Fungi 230,000 <10 <10 <10 <10 Control <10 NT NT NT NT ph 5.00 Baby Wipes Solution on Airlaid, 3 0 C 0 Hours 24 Hrs. 72 Hrs. 1 Week* 2 Week Bacteria 3,000, <10 <10 <10 Fungi 500,000 TNTC TNTC 30 <10 Control <10 NT NT NT NT ph 5.56 Preservative Challenge Testing Water, Aloe Barbadensis Leaf Extract, Glycerin, Potassium Sorbate, Citric Acid Wet wipes solution on Spunlace, 3 0 C 0 Days 24 Hrs 72 Hrs 1 week* 2 weeks 3 weeks 4 weeks Bacteria 2,000,000 <10 <10 <10 <10 <10 <10 Fungi 220, TNTC Control <10 NT NT NT NT NT NT ph 3.46 Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzoate, Potassium Sorbate, Citric Acid Wet Wipe solution on Spunlace, 3 0 C 0 Days 24 Hrs. 72 Hrs. 1 Week* 2 Weeks Bacteria 2,400,000 <10 <10 <10 <10 Fungi 220,000 TNTC 200 <10 <10 Control <10 NT NT NT NT ph

33 Preservative Challenge Testing Water, Aloe Barbadensis Leaf Extract, Glycerin, Sodium Benzoate, Potassium Sorbate, Citric Acid Wet Wipe solution on 100% cotton, 3 0 C 0 Hours 24 Hr. 72 Hrs. 1 Week * 2 Week Bacteria 1,900,000 <10 <10 <10 <10 Fungi 280, <10 <10 <10 Control <10 NT NT NT NT ph 4.63 Preservative Challenge Testing Water, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Glycerin, Ceteareth-12, Cetyl Palmitate, Potassium Sorbate, Phenoxyethanol, Perfume, Tocopheryl Acetate Baby Wipes, Spunlace, (Purchased Product) 0 Hours 24 Hr. 72 Hrs. 1 Week * 2 Week Bacteria 2,700,000 TNTC TNTC TNTC NT Fungi 240,000 TNTC TNTC TNTC NT Control <10 NT NT NT NT ph

34 Preservative Challenge Testing Water, Caprylyl Glycol, Ethylhexylglycerin, Laureth-7 Citrate, Sodium Citrate, Disodium EDTA, Aloe Barbadensis Leaf Juice, Citric Acid Baby Wipe, Spunlace, (Purchased Product) 0 Hours 24 Hr. 72 Hrs. 1 Week * 2 Week Bacteria 2,300,000 <10 <10 <10 <10 Fungi 220, Control <10 NT NT NT NT ph 5.10 Microbial problems in the market? Testing protocol and methods Inadequate product risk assessment 34

35 Microbial problems in the market? Testing protocol and methods Inadequate product risk assessment Raw material changes Manufacture and process changes Microbial problems in the market? Testing protocol and methods Inadequate product risk assessment Raw material changes Manufacture and process changes Environmental conditions Microbial resistance to preservatives 35

36 Microbial problems in the market? Testing protocol and methods Inadequate product risk assessment Raw material changes Manufacture and process changes Environmental conditions Microbial resistance to preservatives Consumer use / misuse Early spoilage prior to shelf life expiration Summary Wet Wipes are a complex system Many factors influence wet wipe preservation 36

37 Summary Wet Wipes are a complex system Many factors influence wet wipe preservation Wet Wipe formulations should include a stand-alone bactericide and fungicide Wet Wipe preservation system must be formulated and thoroughly tested Summary Wet Wipes are a complex system Many factors influence wet wipe preservation Wet Wipe formulations should include a stand-alone bactericide and fungicide Wet Wipe preservation system must be formulated and thoroughly tested Employ proper preservative challenge and stability testing protocols. Consider more stringent test methods Anticipate entire product life cycle when determining adequate wet wipes preservation 37

38 THANK YOU for your help John Yablonski, Bio-Control Services Group, Inc. David Steinberg, Steinberg & Associates, Inc. Zahid Sharif, Rockline Industries Lori Messenbrink, Rockline Industries 38