Pillow packs and unit paks

• 1. What is packaging ? Packaging is defined as the collection of different component which surround the pharmaceutical product from the time of production until its use. Importance of packaging ? Protect against all adverse external influences that can alter the properties of the product. Protect against biological contamination. Protect against physical damage. Carry the correct information and identification of the product.

2. Containment Not to leak, nor allow diffusion and permeation. Strong enough to hold the contents during handling. Protection from: Light Moisture Oxygen Biological contamination Mechanical damage Counterfeiting 3. A desiccant is a Hygroscopic substance that induces or sustains a state of dryness (desiccation) in a moderately well-sealed container. Commonly encountered pre-packaged desiccants are solids, and work through absorption or adsorption of water, or a combination of the two. Pre-packaged desiccant is most commonly used to remove excessive humidity that would normally degrade or even destroy products sensitive to moisture. Some commonly used desiccants are: silica gel, activated charcoal, calcium chloride, montmorillonite clay, and molecular sieves. 4. One measure of desiccant efficiency is the ratio (or percentage) of water storable in the desiccant, relative to the mass of desiccant. Another measure is the residual relative humidity of the air or other fluid being dried. The performance of any desiccant varies with temperature and both relative humidity and absolute humidity. To some extent, desiccant performance can be precisely described, but most commonly, the final choice of which desiccant best suits a given situation, how much of it to use, and in what form, is made based on testing and practical experiment. 5. Pillow paks can be used to absorb moisture, vapor, gas or odor. They are made of non-woven Tyvek material that is manufactured by Dupont. Many great products resulted from accidental laboratory discoveries, such as X-rays, Penicillin, and Post-It Notes. Likewise, Tyvek was discovered in 1955 in an experimental lab when DuPont researcher Jim White noticed white polyethylene fluff coming out of a pipe. This new material went into development and a patent proposal was submitted the following year. In 1965 DuPont trademarked the Tyvek name and commercial production finally began two years later. 6. DuPont Tyvek offers the best characteristics of paper, film, and fabric in one material. Amazingly Light Incredibly Water and Moisture Resistant Tough 100% Recyclable Distinctive Bright white and silky smooth, Tyvek has a distinctive look and feel that enhances graphic images and instantly sets it apart from all other materials. 7. Silica gel is a granular, vitreous, porous form of silicon dioxide made synthetically from sodium silicate. In many items, moisture encourages the growth of mold and spoilage. Through the inclusion of silica gel packets these items can be preserved longer. A molecular sieve is a material containing tiny pores of a precise and uniform size that is used as an adsorbent for gases and liquids. Molecules small enough to pass through are adsorbed while larger molecules are not. A molecular sieve can adsorb water up to 22% of its own weight. 8. Pillow packs range in sizes from 0.25grms to 14grms.Activated carbon, also called activated charcoal, activated coal or carbo activatus, is a form of carbon that has been processed to make it extremely porous and thus to have a very large surface area available for adsorption. 9. ProductCompliancePILLOW PAK (Mfg. ) 21CFR, EC/EU compliantLOCAL POUCHNilDMF No.11871 Type-IIINilDesiccant TypeSilica GelRemarks Pillow Pak is Safe to use for Food/Pharma Grade USFDA Drug Mater File No. (can use with direct contact of food grade product)Silica GelDesiccant FormBeadsBeads/GranularAdsorption Capacity @40%Rh,25C @80%Rh,25C,Min. 22 % Min. 33% 19% 29 %Granular break easily, Powdered Silica produces more fine dust on moisture contact High adsorption capacity for longer protection 10. Substrate (Packet Material)Tyvek Microporous, Spunbonded olefinLinting /Fibers Tearing Strength Of PacketNo Very High Tear strengthDusting PropertiesNon-dustingRegenerationYesPrinting Packet Dimensions COAFood Grade Ink StandardMSDS CostSupplied with each lot Available HighSpun bonded Olefin is Composite Paper better for strength & permeability of moisture Chances are there Fibers may stick to product in which it is used. Packet Integrity Medium strength important to avoid mixups May Create Dust may get mixed with Problem of Dusting product. No Composite Paper will burn at high temperature. Non-Food Grade Safety? Standard On request only Yes MediumPrice or performance????? 11. Parameters Construction Exposure for moisture pick up Ink Marks on Tablets/CapsPillow Packs Tyvek Paper Fast NoRate of adsorption at 90% RH38.5%Regeneration ProcessYesCanister HDPE MediumYes 32% NoFDA ComplianceYes 0.25 gm 14gm1,2,3 gm onlyTyvek also gives higher strength Pillow pack hold advantages Canister - Ink may leave the mark/Color on Tablets/ Capsules More Adsorption power for Pillow Pack 100% Chances to reuse in case of doubt, Being HDPE construction not possibleYesAvailable GramsRemarksShelf Life & storage lifeMin 3 yearsMore range available in Pillow PaksMin 1 yearAdvantage with Pillow packConfusions with TabletsNILMediumEnd user may get confused with shape & size of canister with compared to tablet size.CostLowVery HighCost & better economics with pillow pack 12. Unit Paks are, we can say pillow paks but in larger sizes. 1 unit= 28gms(silica gel, molecular sieve etc) according to MIL-D-3464 specifications. Upon its wartime experience in the development of food and drug drying agents, The U.S. Department of Defense (DOD) developed specifications, addressing the elimination of corrosion and mildew by adsorbing the moisture from the air of an enclosed space. The DOD released MIL-D-3464 covering the use of bagged desiccants for packaging and static dehumidification. MIL-D-3464 specification has become the only objective source for packaging engineers. Sizes: Available in 1/6, 1/3, 1/2, 1, 2, 4, 6, 8, 16 or 80 "unit"