commitment to excellence - pure encapsulations

Commitment to Excellence

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

The Pure Probiotic Initiative

The viability triadProbiotics comprise a rapidly expanding area of evidence-based nutritional support. In addition to widely recognized digestive and immunologic utility, emerging research continues to highlight novel applications. Intersecting many fundamental aspects of health, probiotic products are now empowering clinicians of diverse specialties. The increasing diversity of probiotics commands a thorough emphasis on ingredient identity and potency.*

Decades of scientific discoveries in microbiology have revealed fundamental determinants of survival of commensal bacteria. Furthermore, since probiotics are dynamic organisms with unique requirements and sensitivities, a tightly regulated manufacturing process that exceeds standard GMP compliance is required to guarantee survival and stability.

At Pure Encapsulations, every phase of handling and manufacturing addresses a triad of viability determinants—temperature control, moisture control and timing.

Through systemic innovations in manufacturing, Pure Encapsulations adheres to the most scientifically validated methods for maintaining probiotic quality. This commitment to quality begins at the earliest stage of sourcing and is sustained through the finished product best by date. At every step, Pure Encapsulations accommodates the unique needs and sensitivities of probiotics to deliver the most reliable, clinically effective products to your door.*

TO ORDER CALL 800-753-2277 Secure online ordering and information at www.PureEncapsulations.com2

PROBIOTIC VIABILITY ASSURANCE

MoistureControl

TemperatureControl Timing

Figure 1: The viability triad.


Strain authenticationProbiotics are genetically and functionally diverse, and minor variations can impact biological activity. The expanding taxonomic range of clinically relevant species and strains demands precise and consistent identity confirmation. Pure Encapsulations uses the most current methods available for accurate identification.*

• DNAsequencing.Usingstate-of-the-artDNAsequencingsoftware,sampleribosomalDNAisalignedwithabankedreference sequence; genetic fingerprints must precisely match to verify genus and species.

• FattyAcidMethylEster(FAME)analysis.Additionaltestingisoftenrequiredtoauthenticatespecificstrains.FAMEanalysis matchesafingerprintofbacterialfattyacidcompositionagainstthepatternofaknownreferencestrain.

Independent laboratory testingAll testing is performed by certified independent laboratories. In addition to strain authentication, qualified, independent labs verify potency of raw materials and finished products using the most current quantitative methods for enumerating total colony forming units, orCFU.Inaddition,rawmaterialsandfinishedproductsarethird-partytestedforyeast,moldandpathogenstoensurepurity.

Advanced Laboratories, Inc.

“Building on Analytical Excellence”

IDENTITY AND POTENCY ASSURANCE

3


EXCELLENCE IN SOURCING AND FORMULATION

Our dedication to product quality assurance begins long before ingredients arrive at our facility. Our strains are sourced, formulated and manufactured according to the highest standards of purity, potency and efficacy.*

Strategic sourcingSuppliers must meet strict testing and quality criteria to qualify as a Pure Encapsulations probiotic source. In addition to our stringent requirements for all raw ingredients, these manufacturers must provide proof of genetic identity and storage stability data.

Successful application of these organisms is dependent on their ability to reach the intestine, where they adhere to the lining to exert their beneficial effects. To effectively pass through the stomach and upper intestine intact, probiotics must withstand gastric acid, bile and pancreatic enzymes. The capacity of probiotic strains to tolerate these conditions is among the principal criteria in the sourcing of Pure Encapsulations probiotics(Table1).Onlythestrainsthatarenaturallyresilientare selected to maximize effectiveness.*

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Probiotic Genus, Species, Strain

Acid Tolerance*

Bile Tolerance*

Pancreatin Tolerance

Adherence to Intestinal Cells

Bifidobacterium bifidum (PANDA) +++++ ++++ N/A N/A

Bifidobacterium lactis (Bl-04) +++++ +++++ N/A +++

Bifidobacterium lactis (PANDA) ++++ +++ N/A N/A

Bifidobacterium longum (Bl-05) +++ ++++ N/A +++

Lactobacillus acidophilus (La-14) +++++ +++++ ++++ ++++

Lactobacillus casei (Lc-11) ++++ ++++ N/A +++

Lactobacillus plantarum (Lp-115) +++++ +++++ ++++ +++

Lactobacillus rhamnosus (Lr-32) +++++ +++++ ++++ ++++

Lactobacillus salivarius (Ls-33) +++ ++++ ++++ +++

Lactobacillus sporogenes +++++ +++++ +++++ N/A

Saccharomyces boulardii +++++ +++++ +++++ N/A

Streptococcus thermophilus (St-21) + +++++ N/A ++++

Legend+++++ Excellent++++ Very good+++ Good++ Average+ FairN/A information not available

Data is derived from a compilation of supplier and published studies of simulated gastric and intestinal conditions at physiological pH.

* Survival in acid (pH=2) or bile+++++ >90%++++ 80-89%+++ 70-79%++ 60-69%+ < 50%


Table 1

EXCELLENCE IN MANUFACTURING: A MULTI-STEP PROCESS


The Pure Probiotic Initiative constitutes a multi-step application of the viability triad, addressing every step of handling and manufacturing by controlling temperature, timing and moisture through tightly regulated procedures.

Temperature controlTempering protocols. Freezing and thawing probiotics is a common cause of condensation, which may be lethal to probiotics. Pure Encapsulations circumvents this issue by gradually bringing the material from storage temperature to the manufacturing temperature, aprocessknownastempering.Tooptimizetemperingprotocolsfromstarttofinish:

• Probioticsarepurchasedinsmallvolumesoflessthan5kganddeliveredinrefrigeratedtrucks.Smallerpackagesallowmore precisetempering,reducingtheriskofcondensation.

• Finishedprobioticproductsarestoredindesignatedwalk-incoolersuntilshipment,whicharemaintainedat4°C,auniversally recognizedstoragetemperatureformicroorganisms.Eachshipmentisthenpackagedinaninsulatedcoolerwithfoamicebricks.

Figure 2: Map of controlled operations ensuring viability.


•Duringmanufacturing,temperingprotocolsatvariousstages specify exact time periods required for a given weight of material to reach ambient temperature in a gradual, controlled way to prevent condensation and extreme differences in temperature that compromise viability.

TimingStrict time limits. Critical steps of manufacturing are executed withindefinedtimelimits.Uponreceiptofrawmaterial,enteringthestockintooursystemandobtainingsamplesforidentitytestingare performed as quickly as possible with precision specified bya standard operating procedure. Other sensitive steps, such as weighing and blending, are also executed within strict time limits to minimize contact of the material with ambient moisture.

Moisture controlHumidity control. Relative humidity is monitored and recorded in allroomseverytwohours,includingthewarehouse,walk-incoolersand every production room. Operations proceed only within specific limits. The blending of probiotics uses compressed dry air at a low, tightly controlled dew point, the temperature at which moisture in the air condenses to water.

Proprietary rice-based moisture control. During manufacturing and storage, maintaining probiotics in a resting metabolic state is critical for long-term survival. Minimizing moisture within the capsule environment also maintains metabolic quiescence and viability during storage. To maximize storage stability, our probiotics are formulated to include a proprietary rice base to minimize water activity (Aw), which refers to the ability of water to interact withmicroorganisms (Figure 3). Together with rigorous temperatureand humidity specifications for all stages of production, low-Aw formulation ensures viability of the finished product through its best bydate(Figure4).

Figure 3: Minimizing water activity (Aw) with a proprietaryrice-based moisture control enhances finished product potency.

Figure 4: Pure Encapsulations probiotics meet label claim through their 1-yearbestbydates.

120

100

80

60

40

20

0Bill

ion

CFU

/gra

m

Typical Aw Minimized Aw

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Product Billion live cellsCFU/serving

Label claim confirmed by

independent testing at 13 months

Probiotic-5 10 billion

PureProbiotic 5 billion

Probiotic G.I. 10 billion

Ora-Probiotic 3 billion

Probiotic 123 4.5 billion

Probiotic IMM 5 billion

Saccharomyces Boulardii 5 billion

Lactobacillus Acidophilus 1.5 billion

Lactobacillus Sporogenes 1.5 billion

PureBaby Probiotic 3 billion

Probiotic 50B 50 billion

8 TO ORDER CALL 800-753-2277 Secure online ordering and information at www.PureEncapsulations.com8

PROBIOTIC-5

Species:

• Lactobacillusacidophilus(La-14)

• Lactobacillusrhamnosus(Lr–32)

• Bifidobacteriumlongum(Bl–05)

• Bifidobacteriumlactis(Bl–04)

• Bifidobacteriumbifidum(Bb–06)

Potency:10billionCFU/capsule

Clinical applications: General immune and GI support*

Probiotic-5 – dairy and soy freeeach vegetarian capsule contains v 0

probiotic blend .........................................................................................10 billion CFUproviding:

Lactobacillus acidophilus (La-14) Lactobacillus rhamnosus (Lr-32) Bifidobacterium longum (Bl-05) Bifidobacterium lactis (Bl-04) Bifidobacterium bifidum (Bb-06)

other ingredients: rice starch, silicon dioxide, vegetarian capsule (cellulose, water)

This formula requires refrigeration to maintain culture viability.

1–2 capsules daily, in divided doses, with or between meals.

quantity order code Probiotic-5 60 PRB6

PUREPROBIOTIC


Species:


• Lactobacillusplantarum(Lp-115)

• Lactobacillusrhamnosus(Lr-32)

• Bifidobacteriumlactis(Bl-04)

• Bifidobacteriumbreve(Bb-03)

• Bifidobacteriumbifidum(Bb-06)


Clinical applications: General immune and GI support for highly sensitive individuals*

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PureProbiotic – allergen-freeeach vegetarian capsule contains v 3probiotic blend ...........................................................................................5 billion CFU

providing:Lactobacillus acidophilus (La-14)Lactobacillus plantarum (Lp-115)Lactobacillus rhamnosus (Lr-32)Bifidobacterium lactis (Bl-04)Bifidobacterium breve (Bb-03)Bifidobacterium bifidum (Bb-06)

other ingredients: rice starch, vegetarian capsule (cellulose, water)


Children ages 4 and up: 1 capsule daily, with or between meals. Adults: 2 capsules daily, with or between meals.Powder may be removed from capsule and mixed into cold food or beverage.

quantity order code PureProbiotic 60 PPA6


PROBIOTIC G . I .

Species:


• Lactobacillussalivarius(Ls-33)

• Lactobacilluscasei(Lc-11)


• Streptococcusthermophilus(St-21)


Potency: 10billionCFU/capsule

Clinical applications: Intestinal inflammatory balance*

Relevant mechanisms: Modulatescytokinegeneexpression in intestinal epithelial cells*

Probiotic G.I. – shelf-stable, dairy and soy free

each vegetarian capsule contains v 0probiotic blend .........................................................................................10 billion CFU

providing:Lactobacillus acidophilus (La-14) Lactobacillus salivarius (Ls-33) Lactobacillus casei (Lc-11) Bifidobacterium lactis (Bl-04) Streptococcus thermophilus (St-21)Bifidobacterium bifidum (Bb-06)

other ingredients: rice starch, vegetarian capsule (cellulose, water)

This product does not require refrigeration to maintain culture viability.

1–2 capsules daily, in divided doses, with or between meals.

quantity order code Probiotic G.I. 60 PGI6

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. 11

ORA-PROBIOTIC and PROBIOTIC 123

Species:

• Streptococcussalivarius(BLISK12)

• Lactobacillussalivarius

• Lactobacillusplantarum

• Lactobacillusrhamnosus

• Lactobacillusreuteri

• Bifidobacteriumlactis

Potency: 3billionCFU/capsule

Clinical applications: Oral health*

Relevant mechanisms: Supports inflammatory balance, microbial defense and epithelial cell signaling in mouth and gum tissue*

Species:




Potency: 2.25billionCFU/serving

Clinical applications: General immune and GI support formulated for children*

Ora-Probiotic – chewable tablet

each chewable tablet contains v probiotic blend ...........................................................................................3 billion CFU

providing:Streptococcus salivarius BLIS K12Lactobacillus salivariusLactobacillus plantarumLactobacillus rhamnosusLactobacillus reuteriBifidobacterium lactis

Contains milkother ingredients: lactitol, inulin, cane sugar, dextrose, natural grape flavor, citric acid, glyceryl dibehenate, natural vanilla flavor and other natural flavors, purified stevia extract


Children ages 2 and up: chew slowly 1 tablet daily.Adults: chew slowly 1–2 tablets daily, in divided doses.

quantity order code Ora-Probiotic 60 OPB6

Probiotic 123 – dairy and soy free

each scoop (0.5 g) contains v probiotic blend ......................................................................................2.25 billion CFU

providing: Lactobacillus acidophilus (La-14) Bifidobacterium lactis (Bl-04) Bifidobacterium bifidum (Bb-06)

other ingredients: rice starchThis formula requires refrigeration to maintain culture viability.

Ages 1 to 3, take 1/2 scoop daily.Ages 4 and up, take 1 scoop daily, or as directed by a health professional.Mix with applesauce or yogurt.

quantity order code Probiotic 123 80 g PRO8

PROBIOTIC IMM

TO ORDER CALL 800-753-2277 Secure online ordering and information at www.PureEncapsulations.com

Species:

• Bifidobacteriumlongum(BB536)



• Lactobacilluscasei(Lc-11)



Clinical applications: Eye, nasal and throat health*

Relevant mechanisms: Maintains healthy IgE production and mast cell integrity in the nasal lining and upper respiratory tract*

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Probiotic IMM – shelf-stableeach vegetarian capsule contains

v 3

probiotic blend ...........................................................................................5 billion CFUproviding:

Bifidobacterium longum (BB536)Bifidobacterium lactis (Bl-04)Lactobacillus acidophilus (La-14)Lactobacillus casei (Lc-11)Lactobacillus plantarum (Lp-115)

Contains milkother ingredients: rice starch, tapioca starch, calcium phosphate, vegetarian capsule (cellulose, water)

1–2 capsules daily, with or between meals.

quantity order code Probiotic IMM 60 PRI6


STAND ALONE STRAINS


Clinical applications: Colon motility and microbial balance*

Potency:1.5billionCFU/capsule


Potency:1.5billionCFU/capsule


Saccharomyces boulardii each vegetarian capsule contains v 00

Saccharomyces boulardii ...................................................................... 5 billion CFUother ingredients: rice starch, vegetarian capsule (cellulose, water)


4 capsules daily, in divided doses, between meals.

quantity order code

Saccharomyces boulardii 60 SB6

Lactobacillus Acidophilus each vegetarian capsule contains v 0

Lactobacillus acidophilus, LA-5® ........................................................1.5 billion CFUContains dairyother ingredients: rice starch, vegetarian capsule (cellulose, water)


1–3 capsules daily, in divided doses, between meals.

quantity order code

Lactobacillus Acidophilus 60 LA6

LA-5® is a registered trademark of Chr. Hansen.

Lactobacillus Sporogenes – shelf-stableeach vegetarian capsule contains v 0

Lactobacillus sporogenes .................................................................. 1.5 billion CFUother ingredients: rice starch, vegetarian capsule (cellulose, water)

This formula does not require refrigeration to maintain culture viability.

1–3 capsules daily, in divided doses, between meals.

quantity order code

Lactobacillus Sporogenes 60 LS6

PUREBABY PROBIOTIC

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Species:

• Bifidobacteriumbifidum

• Bifidobacteriumlactis

• Lactococcuslactis

Potency:3billionCFU/sachet

Clinical applications: Clinically studied for immune andskinhealthinpregnantwomenandinfants*

TO ORDER CALL 800-753-2277 Secure online ordering and information at www.PureEncapsulations.com

PureBaby Probiotic – shelf-stable1 sachet (3 g) contains v

calories .........................................................................................................................10total carbohydrate .................................................................................................... 3 gproprietary blend Ecologic® PANDA .....................................................3 billion CFU

providing: bifidobacterium bifidum, bifidobacterium lactis, lactococcus lactis

Contains milk, soyother ingredients: rice starch, maltodextrin, ascorbic acid

This product does not require refrigeration.

serving size: 3 g (1 sachet)servings per container: 30

Pregnant Women (starting at 34 weeks): As a dietary supplement, dissolve the contents of 1 sachet with water, juice or milk. Take once daily, preferably between meals.

Infant Dose (Bottle Fed): As a dietary supplement, dissolve the contents of 1 sachet in breast milk or formula through age 12 months. Children 12–24 months may continue with 1 sachet dissolved in water, juice or milk, preferably between meals.

Infant Dose (Breast Fed): Mother takes product according to recommendations for pregnant women.

quantity order code

PureBaby Probiotic 30 sachets PPR3

Ecologic® PANDA is a multi-species probiotic product designed and produced by Winclove Bio Industries, BV in Amsterdam, the Netherlands.

15*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

PUREBABY PROBIOTIC PROBIOTIC 50B

Species:



• Lactobacillusrhamnosus(Lr-32)


• Bifidobacteriumlongum(Bl-05)


Clinical applications: Advanced immune and gastrointestinal support*


Probiotic 50B – dairy and soy freeeach vegetarian capsule contains v 00probiotic blend .........................................................................................50 billion CFU

providing:Lactobacillus plantarum (Lp-115)Lactobacillus acidophilus (La-14) Lactobacillus rhamnosus (Lr-32) Bifidobacterium lactis (Bl-04) Bifidobacterium longum (Bl-05)

other ingredients: rice starch, vegetarian capsule (cellulose, gellan gum, water)

This product requires refrigeration to maintain culture viability.

1 capsule daily, with or between meals.

quantity order code

Probiotic 50B 60 PR506


Every step of Pure Encapsulations probiotic product development and manufacturing is designed to ensure the viability of the individual organisms. This process, together with independent laboratory authentication and testing, exemplifies our long-standing, rigorous dedication to finished product quality assurance for maximal clinical efficacy.*

Pure Encapsulations, Inc., 490 Boston Post Road, Sudbury, Massachusetts 01776 [email protected] | www.PureEncapsulations.com | T: 800-753-2277 | F: 888-783-2277

commitment to excellence - pure encapsulations

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