ATYPICAL PRODUCT PRESERVATION

Transcription

1 ATYPICAL PRODUCT PRESERVATION Phil Geis Geis Microbiological Quality and Advanced Testing Laboratory Atypical What are Atypical and Typical Range of Atypical Applications Impact on Risk Assessments Dissect Atypical with Examples Closing Thoughts Atypical product rarely fits into an existing risk manufacturing and consumer use assessments. 1

2 What is Atypical Atypical - departure from conventional production, product formulation, packaging and use. Atypical = Innovation I shall not today attempt further to define the kinds of material I understand to be embraced within that shorthand description ["hard-core pornography"]; and perhaps I could never succeed in intelligibly doing so. But I know it when I see it, Justice Potter Stewart, concurring opinion in Jacobellis v. Ohio 378 U.S. 184 (1964), What is Atypical Departure from the established production, products and product use can establish greater microbiological risk. An atypical product is rarely divergent only as final product but can establish new raw materials, formulation, processing and consumer use dynamics that affect risk assessment. 2

3 Range of Atypical Impact Preservation Preservation: chemical, temporal, physical, procedural means to establish and maintain microbiological quality, including: chemicals ph Aw Temperature Time physical barriers/packaging process controls: SOP s, C&S, etc. 3

4 What is Typical Conventional, domestically-supplied raw materials Batch process direct to packout One-dimensional, conventionally-preserved solution/suspension/emulsion HDPE packaging with simple binary closure and no application device Within consumer experience and established practices Range of the Atypicals Raw materials Process Formula Package Delivery Consumer use 4

5 Atypical by Raw Materials/ Process Chemical synthesis/in-process modification Natural, organic ingredients Geographically remote sourcing Complexity of premixes Continuous process In-process differentiation Aseptic manufacturing/terminal Sterilization Geographically/culturally remote making Atypical by Formulation Unique emulsions water in silicone oil Multiple phases ribbons, beads Natural ingredients Preservative Free Natural preservatives 5

6 Atypical by Packaging/Delivery Refillable/dilutable products Unique compositions and modified designbiodegradable and recycled plastics, clear packaging Novel/modified delivery devices wipe, pad, pens, doefoot, unintended product reserviour Multiple compartments Nonaerosol aerosols Wooden pallets Atypical by Consumer Use Refillable containers Dilutable products Artistic and idiosyncratic application Geographic, climatic and cultural distribution and market variations Consumer imagination 6

7 Examples Typical Shampoo made Atypical Continuous process Substrate Unique emulsion Natural preservation Preservative free Applicators Typical Product Risk Assessment - Shampoo Identify and address domain of risk Typical product as shampoo Raw materials O 3 water, NH 4 or Na surfactant, silicone, salts Formulation microemulsion, solution Process single batch, C&S controlled Package virgin HDPE with flip cap Consumer potential late use dilution Primary risk assessment effort is making and consumer use 7

8 Typical Product - Shampoo 15 Typical Product - Shampoo PET AOAC USP + Plant relevant isolates 8

9 Typical Product - Shampoo Microbiological Risk Control Package Preservative - simple Highly water soluble Highly effective vs. bacteria Unaffected by surfactants Primary CMIT + minors Historic Formaldehyde releasers Atypical Process - Continuous Batch process Continuous process Packout 9

10 Atypical Process - Substrate Feuchtes Toilet moist toilet paper - mold and yeast contamination. Preservatives: Phenoxyethanol, Methyl-, Ethyl-, Propyl-, Butyl parabens, Sodium Benzoate, PHMB Speculate a process failure Qualification by PET testing juice Atypical in Process Substrate Wipes Partitioning Chromatography Bottom fill Top fill 10

11 Atypical in Process Substrate Uncontrolled Risk - Finished Product Preservation Preservative choice highly aq. Soluble non-substantive Challenge test Juice as premix Representative samples top/ bottom - entire tub Chemical analysis of effective distribution Atypical in Process - Substrate 11

12 Atypical Product Process/Formula Atypical Emulsion Water in silicone oil Failed PET but no contamination in use. Water-in-Oil Oil-in-Water No-P Bugs P-no Bugs Preservation: highly soluble, water preservative Atypical Product Process/Formula Water-in-Silicone Oil Emulsion Preservation: - Target water - Package 12

13 Atypical in Formula Natural Preservation Oil of - Rosemary, Thyme, Neem, Tea Tree, Hinokitol Composition/Efficacy Complex mix fatty acids, oils, ketones, etc. Variable efficacy : seasonal, geographic and part of plant extracted Less and more variable efficacy than traditional preservatives Risk manufacturing, consumer contamination Atypical in Formula Natural Preservation Risk manufacturing, consumer contamination Process controls and packaging successful for traditional preservatives may not be adequate Testing - PET minimal level of efficacy - In-use Preservative analytical specification 13

14 Atypical in Formula Natural Preservation - Additional Process and Package controls - Anal. spec for preservation Atypical in Package Preservative-Free - Package as Preservative Preservative-free cosmetics with new packaging, claims Aptar 12/12/10--Aptar beauty + home claims that its new Irresistible pump protects cosmetics from contamination. Thereby reducing, even eliminating, the need for preservatives Irresistible sterilising pump 14

15 Atypical in Package Preservative-Free - Package as Preservative Preservation is the process and package QA and In-use testing as qualification Process - aseptic or terminal sterilization Package critical performance spec s Irresistible sterilising pump Atypical in Process - Package Preservative- Free - Critical Process controls - Performance spec for package 15

16 Atypical in Package/Delivery Unique applicators Precedent Corneal ulcer associated with contamination of aerosol saline spray tip. Am J Ophthalmol. 1997;124:395. No microbial contamination in can but the spray tip was contaminated with P. aeruginosa. ss_pen_lip_gloss.jpg echnic-fruity-lip-gloss-applicator-brush.jpg pplicators.jpg Atypical in Package/Delivery Risk: greatest in applicator device/tip surface/product ratio, oxidation, light exposure intimate application, dilution with body fluids Challenge testing: In-use Dip inoculations Preservation (similar to powders): Anhydrous, minimal water Diols, parabens Identify and address domain of risk 16

17 Atypical in Package/Delivery Unique Applicator In-use and dip test Anhydrous, low-water, parabens, diols Atypical in Package/Delivery Preservation is the process and package QA and In-use testing as qualification Process - aseptic or terminal sterilization Package critical performance specifications Confirmed with in-use testing 17

18 Preservation of the Atypical Atypical Products as Departures from the Typical Existing Risk Assessments rarely adequate Process Raws, Flow paths, Premixes Compromise in preservation balanced with greater control in process. Products Greater complexity of preservation Compromise in preservation must be balanced with greater control. Qualification In-use testing Analytical and performance specifications Preservation of the Atypical Atypical Products as Departures from the Typical Atypical is Multifactorial Existing Risk Assessments rarely adequate 18