Desiccant and Pharmaceutical coil for Packaging Saurav Anand
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Transcript of Desiccant and Pharmaceutical coil for Packaging Saurav Anand
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DESICCANT FOR PHARMACEUTICAL APPLICATION &
PHARMACEUTICALCOIL
COTTON/RAYON/POLYESTER
DESICCANT INSERT
Saurav AnandIIP, MBA
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DESICCANT
DESICCANTS ARE HYGROSCOPIC SUBSTANCE THAT REMOVE MOISTURE FROM ITS SURROUNDING. ENVIRNMENT,OR SAY IT ATTRACT & RETAIN WATER VAPOR TOWARDS ITSELF. Syn; HYGROSCOPY,DELIQUESCENCE,HUMECTANTWORKING PRINCIPLE OF DESICCANT.
ABSORBENT TYPE WATER ABSORB INTO THE DESICCANT. LARGE ABSORBING CAPACITY. NOT RE-USED.
Ex-- CaO.
ADSORBENT TYPE WATER ADSORB ONTO (SURFACE AREA) THE DESICCANT. SMALLER ADSORBING CAPACITY. RE-USED.
Ex-- SILICA GEL.
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ADSORPTION PHENOMENA
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COMMON PRINCIPLEDESICCANT REMOVE WATER FROM THE AIR
SPACE BY: SINGLE LAEYR & MULTI-LAYER ADSORBPTION:
IT DEPENDS ON FORCE OF ATTRACTION
(BETWEEN ADSORBENT AND ADSORBATE)
PORE SIZE OF DESICCANT VAPOR PRESSUR DIFFERENCE BETWEEN
ADSORBENT SURFACE AND ENVIRONMENT CAPILLARY CONDENSATION---THE SMALLER
PORES BECOME FILLED WITH WATER
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REASON FOR DESICCANT USE PROTECT FROM CORROSION, MOLD
MILDEW GROW.
PREVENT FROM TABLET STICKNESS.
PREVENT FROM HYDROLYSIS OF DRUG.
TO PREVENT NEW DRUG AND
EFFERVECENT TABLET DURING PACKAGING.
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LIST OF COMMON DESICCANT
SILICA GEL INDICATING SILICA GELSMOLECULAR SIEVESDESICCANT CLAY
(MONTMORILLONITE CLAY) CALCIUM OXIDE
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SILICA GEL (SiO2) Amorphous micro-porous structure. High Surface Area (around 800 m²/g) Pore opening sizes 3-60 ۫ A ۫. Best Performance At
RT (70° to 90°F).
HIGH RH (60 to 90% RH). Non-Corrosive, Nontoxic Nature US FDA Approved for use in Food
& Drug packaging.
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MOL. STRUCTURE
Regenerated temp-120 ْ C Adsorb up to one third of its own weight
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INDICATING SILICA GEL(ISG) Visual color change Contain- Cobalt chloride
(Colour Developer) (CoCl2) (CoCl2•2H2O)
H2O [Co(H2O)6]Cl2
The color changes as the desiccant goes past 8%
moisture levels (by wt)
Indicates it is time to
replace the desiccant
DRYISG
WETISG
NORMALSILICA
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MOLECULAR SIEVE (SYNTHETIC ZEOLITE) FORMULA-Myx/y[AlxSi1–xO2].
Ex---Na20.A1203.(Si02)x.(H20)y. Crystalline Structure with uniform pore size Adsorptive surface area 700 to 800 sq. m per g Adsorb moisture at low as well as high RH. 3A (pore size 3 Å): Adsorbs NH3, H2O,
4A (pore size 4 Å): Adsorbs H2O, CO2, SO2, H2S, C2H4, C2H6, C3H6, EtOH
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CONTD….
Muddy powder like
Higher in cost per unit, but extremely large range of adsorptive capabilities.
Manufactured
Gelling process.
Clay process.
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MONTMORILLONITE CLAY Naturally occurring Porous adsorbent Main component is the layered mineral Ca-
montmorillonite,Ca0.16[Al1.68Mg0.32(OH)2(Si4O10)] Adsorbent property is created by the controlled
drying naturally occurring Clay Clay reacts relatively slowly at low as well as high humidity levels
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CONTD…. Best performance at below 120°F
(approximately 50°C), above 120°F, possibility that the clay will give-up moisture (Storage Condition should mention )
Work good at LOW as well
HIGH RH condition Least expensive desiccant
per pound
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CALCIUM OXIDE(CaO) ABSORPTION PROCESS ACT SLOWLY, It take a days to reach its maximum capacity CaO(s) + H2O(l) Ca(OH)2(s) + (heat) Absorbs moisture, it SWELLS. Proper desiccant
packaging is required for effective use Limited to primarily the packaging of dehydrated FOODS
Absorb a much greater amount of water at low relative humidity
Retain moisture at high temp Relatively inexpensive
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COMPARISON SHEET OF DESICCANT
Property Molecular
Sieve Silica
Gel Montmorillonite Clay
CaO CaSO4
Adsorptive Capacity at low H20 Conc.
Excellent Poor Fair Excellent
Good
Rate of Adsorption Excellent Good Good Poor Good
Capacity for Water
@77° F, 40% RH High High Medium High Low
Separation by
Molecular Sizes Yes No No No No
Adsorptive Capacity
at Elevated Temp. Excellent Poor Poor Good Good
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COMPARISON GRAPH OF DESICCANT
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EQUILIBRIUM H2O CAPACITY
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AMOUNT OF DESICCANT Volume of air space to be desiccated Nature of the material to be protected Moisture surrounding to the package Type of desiccant to be used Length of time for protection Atmospheric conditions (Temp & RH)
when/where the product is packed, sealed, shipment and storage
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WATER CONTAMINATION IN A CLOSED CONTAINER
The water vapor in the air inside the package The water vapor adsorbed by the materials
inside the package The water vapor on the walls of the package The permeation of water vapor into the
package
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Choosing the Right Solution for DesiccantTwo main parameter Adsorption Capacity Adsorption Rate weight, size, and shape restrictions of the
package; dust requirements; process restrictions; and cost
Adsorption Capacity Mtotal = Minitial + Minflow (Mheadspace + Mrm) + Minflow
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THE AMOUNT OF DESICCANT…. Mtotal / The adsorption capacity of the desiccant at the
maximum allowable relative humidity. Ex Mtotal = 0.1 g The maximum allowable relative humidity is 20%, the
adsorption capacity of desiccant clay is 13%. Amount of clay needed is 0.78g (0.1 / 0.13) Under these same conditions. silica gel = 0.87g molecular sieve = 0.55g We Take nearest standard desiccant product size. For the
above example, 1 g of clay, 1 g of silica gel, or 0.75 g of molecular sieve would suffice
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THE AMOUNT OF DESICCANT….
Adsorption Rate Time taken to reduce the relative humidity
in a closed container from 20% to virtually 0%
Molecular sieve--within 5 minutes Desiccant clay -- within 20 minutes Silica gel-- About 60 minutes In most cases, the kinetics for desorption of
water from the product are slower than the adsorption kinetics of the desiccant
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THE AMOUNT OF DESICCANT…. In packaging line Moisture uptake during
this exposure time reduces the desiccant's adsorption capacity
For example:
1) Small molecular sieve packets are extremely difficult to handle and require humidity control during dispensing
2) Desiccant canisters, inserts, and stoppers react more slowly than packets or tablets
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UNIT OF DESICCANT
IN 1973,THE DOD (In USA) FOLLOWED WITH SPECIFICATIONS FOR DESICCANT IN PACKAGING OF ITEMS•MIL-D-3464 and MIL-P-116.(USA Army)•DIN 55473 and 55474(In Europe)•TL 6850 - 008 (German Army) 3 grams at 20% Relative Humidity6 grams at 40% Relative HumidityA "Unit" At 77°F (25°C)Clay = 33g. Silica gel = 28gMolecular sieve = 28g
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DESICCANT PRODUCTS CANISTERS--sizes =13.9x17.8mm,13.9x25.7mm,and 19.4 x
15.8 mm. diameter. Weight of desiccant fill-- 0.25g and 27g High-speed product insertion. less potential for contamination and machine jamming PACKETS--Weight of desiccant fill- 0.25 g and 10 g Face stock materials-- DTII (polyester and polyolefin non woven) Tyvek (spun bonded polyolefin) TABLETS & CAPSULE--Any size and shape Accommodate high-speed production Capsule with silica gel used Freeze drier, 000 Size
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CONT…. CAP INSERTS-- Fit into screw-on caps No extra space No equipment is needed to insert TUBE AND STOPPER SYSTEM-- Most advanced moisture-protection Child resistance. tamper evidence Tight-fitting, vacuum-sealed package. APPLICATION—Diagnostic and pharmaceutical Protect from moisture damage as well as crushing DESICCANT-FILLED POLYMERS— Outer layer--moisture-impermeable material Inner layer-- desiccant-filled polymer material ALCAN-(oPA/Adhesive/Primer/Alu/Tie layer/PE+Desiccant/PE)
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CONT…. HOT-MELT DESICCANTS--
Use in any-volume containers
Using hot-melt equipment and applied
directly to packaging materials.
The non dusting, non toxic USED IN-- sealed pouches, bottles, and blister packs
DESICCANT TAPE--Supplied in either rolls or precut strips
Available in either silica-gel or molecular-sieve.
Adapt easily to existing labeling equipment.
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NEW TECHNOLOGIES DESICCANT NEW AIDS and CANCER DRUG High moisture and oxygen Sensitive “Technology That protects a product from
oxidation, and it works really well at low relative humidities,”
packaging for effervescence tablets and for pharmaceutical powders,”
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CONT… Desiccant polymer tubes The tubes have
desiccant protection injection molded into the polymer itself.
Desiccant Lined Vials One piece desiccant lined vials for use with moisture sensitive blood glucose diagnostic strips, medical devices or effervescent vitamin tablets.
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Desiccant Plastics: DESICCANT ACTIVE POUCH
CONT.
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CONT
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TYPE
COTTON REYON POLYESTER
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PHARMACEUTICAL COILS Pharmaceutical coil is substance that
ensures freshness and stability to the product during shipping and storing.
Pharmaceutical coil provide Cushioning. Safe for Tablets. Absorb dust. Economical aesthetically pleasing.
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COTTONFEATUERES
Natural fiber. Cuts easily. Moisture content is NMT 8.0%. Creates a dry environment inside
the bottle. Biodegradable. Used in bottling of tablets and
capsules
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RAYON FEATURES Man-made fiber (cellulose). Uniform fiber length. Cuts or tears easily.(Dull Knife) Moisture content is NMT 11%. Biodegradable. Most commonly used in the bottling
of tablets and capsules.
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POLYESTERFEATURES
Man-made fiber (petroleum derived). Uniform in fiber length. Non-fluorescent. Non-absorbent – will not introduce
moisture or extract. Moisture content is NMT 1%. Used in bottling of soft-gel capsules.
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PHARMACEUTICAL COILFACTS Gram weight - the weight of the coil
per one yard length. Standard industry gram weights 9 grams12 grams16 grams Cotton and rayon coil meets USP and
EP standards
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REGULATORY REQUIRMENTS USP. IP. EP. Excess residual peroxide has been observed to
produce stability problems in tablets. Furfural and other aldehydes can cause
gelatin crosslinking. The polyester threads are usually coated with a
solutioncontaining lubricants, emulsifiers,and antistatic agents. Polyester should comply with applicable sections of 21 CFR.
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