Published on March 3, 2014
• 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.
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
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.
• 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.
• 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.
• 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.
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.
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.
Product Compliance PILLOW PAK® (Mfg. ) 21CFR, EC/EU compliant LOCAL POUCH Nil DMF No. 11871 Type-III Nil Desiccant Type Silica Gel Remarks 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 Gel Desiccant Form Beads Beads/Granular Adsorption Capacity @40%Rh,25ºC @80%Rh,25ºC, Min. 22 % Min. 33% ≥ 19% ≥ 29 % Granular break easily, Powdered Silica produces more fine dust on moisture contact High adsorption capacity for longer protection
Substrate (Packet Material) Tyvek Microporous, Spunbonded olefin Linting /Fibers Tearing Strength Of Packet No Very High Tear strength Dusting Properties Non-dusting Regeneration Yes Printing Packet Dimensions COA Food Grade Ink Standard MSDS Cost Supplied with each lot Available High Spun 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 Medium Price or performance?????
Parameters Construction Exposure for moisture pick up Ink Marks on Tablets/Caps Pillow Packs Tyvek Paper Fast No Rate of adsorption at 90% RH 38.5% Regeneration Process Yes Canister HDPE Medium Yes 32% No FDA Compliance Yes 0.25 gm – 14gm 1,2,3 gm only Tyvek 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 possible Yes Available Grams Remarks Shelf Life & storage life Min 3 years More range available in Pillow Paks Min 1 year Advantage with Pillow pack Confusions with Tablets NIL Medium End user may get confused with shape & size of canister with compared to tablet size. Cost Low Very High Cost & better economics with pillow pack
• 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 it’s 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"
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