Packaging on health food
I. BAHAN kemasan alufoil
A. Bahan Baku
1. Film
Bahan baku berupa film mempunyai beberapa jenis yaitu :
- Cellophane : terdiri dari 2 jenis : MST (Moisture Transparant) dengan ketebalan antara lain 22μm dan PT (Plant Transparant) dengan ketebalan antara lain 20μm.
- PET (Polyester) : memiliki ketebalan antara lain 12μm.
- OPP (Oriented Polypropylene) : memiliki ketebalan antara lain 20μm, 25μm.
- Nylon : memiliki ketebalan antara lain 15μm, 20μm.
2. Resin
Bahan baku berupa resin mempunyai beberapa jenis yaitu :
- Polyethylene (PE)
- Polyester (PET)
- Polypropylene (PP)
3. Aluminium
Bahan baku berupa aluminium ini terdiri dari satu jenis saja namun mempunyai beberapa ketebalan, misalnya 7μm, 12μm, 20μm, 40μm.
4. Plastik
Bahan baku berupa plastik mempunyai beberapa jenis antara lain :
- LDPE (Low Density Polethylene)
- LLDPE (Low Linear Density Polyethylene)
- HDPE (High Density Polyethylene)
5. Adhesive
Bahan baku berupa adhesive terdiri dari beberapa jenis merk, misalnya Pentacol. Untuk merk Pentacol sendiri mempunyai beberapa type yang formulanya dibuat oleh R&D.
B. Bahan pendukung
1. Tinta
Bahan pendukung berupa tinta mempunyai 2 jenis yaitu tinta biasa dan tinta UV. Tinta UV ini biasanya digunakan untuk bahan kemas yang memerlukan pengamanan yang lebih baik untuk menghindari pemalsuan. Tinta UV ini dapat dilihat dengan jelas di bawah sinar UV.
2. Solvent/ pelarut
Bahan pendukung berupa sovent ini digunakan untuk bermacam-macam keperluan antara lain sebagai pelarut.
DASAR PERTIMBANGAN DESAIN
1. Produk
Pemilihan desain perlu mempertimbangkan produk yang akan dikemas. Produk bisa dalam bentuk cair (liquid), serbuk (powder), kapsul, tablet, dan sebagainya. Selain itu untuk produk obat ethical (resep), obat bebas atau OTC (Over The Counter), maupun produk makanan mempunyai pertimbangan desain yang berbeda.
2. Penampilan
Dari segi penampilan, obat ethical biasanya memiliki desain yang lebih sederhana bila dibandingkan dengan OTC.
3. Mesin Packaging
Mesin packaging berpengaruh pada bentuk sediaan yang akan kita buat termasuk spesifikasi mesin dan kapasitas. Sebagai contoh untuk spesifikasi mesin adalah desain harus dibuat dengan layout vertikal atau horizontal, desain dibuat dengan berapa line, dan sebagainya.
4. Penanganan dan Distribusi
Desain yang dibuat harus mempertimbangkan pengaruh di atas untuk menjamin bahwa konsumen akan menerima produk yang masih memenuhi standard mutu yang telah ditetapkan.
5. Cost atau biaya
Pembuatan desain harus mempertimbangkan biaya. Dari segi bahan kemas, komposisi atau bahan dari bahan kemas yang dipakai harus menjamin kualitas produk itu sendiri dengan biaya yang seminim mungkin.
Pada dasarnya, bahan kemas dalam bentuk sachet mempunyai beberapa bagian penting : (catatan : sachet diambil sebagai contoh karena produk-produk PT. Bintang Toedjoe sebagian besar dikemas dalam bentuk sachet).
1. Surface film : - mempunyai kemampuan untuk dicetak (printability)
- sebagai bagian penting dalam informasi dan promosi (marketability)
2. Bulk layer : - ketebalan berpengaruh pada penanganan produk
- melindungi dari keretakan atau celah yang berakibat pada produk
3. Barrier layer : melindungi produk dari kelembaban dan oksigen dari luar
4. Sealant layer : suhu pada saat sealing sangat berpengaruh.
Surface film choices
1. BOPP (Polypropylene Film)
- Good print substrate
- Low melt point
- Good moisture barrier
- Excellent durability
- Low cost
- Chemical resistance
2. PET (Polyester Film)
- Good print substrate
- High melt point
- Moderate (H2O dan O2) barrier
- High tensile strength dan stiffness
- Thermal stability
- Chemical Resistance
- High initial tear strength
- Good clarity
3. BONY (Oriented Nylon Film)
- Good print substrate
- High melt point
- High Toughness
- Poor moisture barrier
4. KCello (PVDC Coated Cello)
- Moderate print substrate
- No melt point (paper)
- Moderate moisture barrier
- High cost
- Easy tear
Bulk layer choices
1. LDPE (Common bulk layer)
- Good moisture barrier
- Low cost
- Easy to process
- Low foil adhesion
- Low stiffness
2. Nurcel ® AE/ LDPE
- Good moisture barrier
- Low cost
- Easy to process
- Better adhesion to foil than pure LDPE
- Low stiffness
3. EAA
- Good moisture barrier
- Easy to process
- High metal adhesion
- Low stiffness
- Higher cost than PE and Nurcel ® AE blend
Barrier layer choices
1. Foil
- Good flavour/ water barrier
- Poor flex crack resistance
- Moderate cost
2. Metallization (on PET)
- Moderate oxygen barrier
- Good flavor/ chemical barrier
- Adhesion Limitation
- Some ESCR problems
3. PVDC (Coated on BOPP/ PET or Cello)
- Moderate to good flavour/ water barrier
- Coated films generally expensive
4. EVOH (Ethylene Vinyl Alcohol)
- Excellent flavour/ chemical barrier
- Needs co-extrution technology
- Poor moisture barrier
- High cost
5. Nylon film
- Good flavour/chemical barrier
- Poor moisture barrier
- High tear resistance
6. PVOH Coated PE
- Excellent flavour/chemical barrier
- Chloride free (environmental friendly)
- Poor moisture barrier
Sealant Choices
- LDPE - EAA/EMAA
- LLDPE - Surlyn ®
- mPE - Elvaloy ®
- EVA - Elvaloy ® + LDPE
LDPE VS LLDPE
LDPE LLDPE
1. Lower sealing temperature 105℃, VS 120℃ for LLDPE • Better film propertier : stronger, tougher, stiffer VS LDPE
2. Easier to process, especially in extrution coating • Better hot tack VS LDPE
• Is often blended with LDPE or EVA to improve precessing
Blisterpackaging Materials for Pharmaceuticals
Please note we do not supply any materials; this page is for information only. If you would like to contribute to this section please contact us at info@sepha.com
What are the main considerations when selecting suitable blisterpacking materials?
The choice of forming and sealing materials used depends on the degree to which the product needs to be protected from light, heat and moisture. Each material has different resistance to each of these elements and will affect the shelf life and storage conditions of the packaged drugs. Tests are usually carried out during a drug's development (stability studies) to identify which materials are most suitable, bearing in mind the differing cost implications.
The plastic forming films such as polyvinyl chloride (PVC), polypropylene (PP) and polyester (PET) are thermoformed, and are usually colorless and transparent. However for child-proof packs, or if the drug must be protected from light, forming films can also be opaque.
Forming Films
The forming film is the packaging component that receives the product in deep drawn pockets. Plastic forming films such as polypropylene (PP), polyvinyl chloride (PVC) can be thermoformed, but support materials containing aluminum are cold formed. The forming film and lidding material are an integrated package and must match one another precisely.
The forming film is usually colorless and transparent. However if the manufacturer wishes to make a childproof package, or if the drug must be protected from light, then forming films can also be opaque.
PVC (polyvinyl chloride)
(Contributed by : Helmuth Leitner, Solvay SolVin, Sept 2004)
PVC used as a forming film is called rigid PVC because it is almost free of softening agents. Currently it is the most widely used forming film and displays ideal forming characteristics. Its water-vapor permeability is very low. However, PVC was widely criticized because its combustion results in hydrochloride emissions, and if combustion takes place under certain conditions it can produce dioxins. New studies* have shown that in today's incineration plants PVC doesn't create any problem and energy recovery of plastics including PVC is a sustainable operation.
* References:
1. Wikstrøm, E., 1999. The Role of Chlorine during Waste Combustion. Thesis - Umeå University ; Wikstrøm, E., 2000. Final Report
2. Umeå-study. Doctoral thesis by E. Wikstrøm, University of Umeå, Sweden The role of Chlorine during Waste Combustion (Wikstrøm, 1999).
3. Doris Menke, Hiltrud Fiedler und Dr.-Ing. Heiner Zwahr; Mull und abfall 6-02, June 2002, page 322-332, ISSN 0027-2957.
4. PVC and municipal solid waste combustion : burden or benefit ? by LPM Rijpkema TNO report R 99/462 . Institute of Environmental Sciences, Energy Research and Process Innovation. TNO-MEP P.O. Box 342 7300 AH Apeldoorn, The Netherlands. Phone : 31 55 549 34 93 fx : 31 55 541 98 37
PVDC (polyvinylidene chloride)
PVDC-coated PVC has characteristics similar to those of uncoated PVC except that the water vapor permeability of films coated in this way is reduced by a factor of 5-10. The coating is applied on one side and usually faces the product and the lidding material.
PVC and ACLAR (CTFE)
PVC-CTFE films made from PVC and ACLAR (CTFE) have the lowest water-vapor permeability of all the films used for blisterpackaging. The environmental concerns raised about PVC also apply to PVC-CTFE film.
WHAT IS ACLAR®?
Aclar fluoropolymer film is a polychlorotrifluoroethylene (PCTFE) material manufactured by Honeywell that is used extensively in pharmaceutical packaging and many other applications for its excellent moisture barrier and chemical stability. Aclar film is crystal clear, biochemically inert, chemical-resistant, nonflammable, plasticizer- and stabilizer-free, and antistatic, and it possesses excellent electrical properties, as well as a very low coefficient of friction.
www.aclar.com
PP (polypropylene)
There is an increasing trend towards the use of PP as a support material for blister packages. The water-vapor permeability of uncoated PP is lower than that of PVC and is comparable to the water vapor permeability of PVDC coated PVC. One problem posed by PP processing is thermoforming. The temperature required for thermoforming PP and the temperature of the subsequent cooling process must be precisely controlled.
Another problem is warping of package - often resulting in the requirement for PP formed packages to be straightened before cartoning.
New High Barrier Thermoforming Film.
There is a new high barrier thermoforming film based on a new type of plastic granules called COC (cyclo-olefine copolymer). It is suitable for pharmaceutical and cosmetic packaging applications, where excellent moisture barrier properties, outstanding transparency and good rigidity are required.
There are different structures available of which the common ones are:
30 my PP / 190 my COC / 30 my PP - AMPARIS 190
30 my PP / 300 my COC / 30 my PP - AMPARIS 300
The COC films are solvent-free laminated to both sides with 30 micron PP films, consequently the laminate is free from solvents. The packaging system in combination with PP-sealable aluminum push-thru lidding foils guarantees a high seal integrity. Peel and peel-push laminates are also available.
The AMPARIS films can be thermoformed on existing blister lines for PVC, PVC/PVDC and ACLAR.
These new films are sold by Algroup Wheaton under the trade name Amparis.
AMPARIS® is the latest innovation in high barrier thermoformable films, offering excellent moisture properties, outstanding transparency and high rigidity. It is available as a laminate or co-extrusion film (Polybar®).
This plastic laminate uses a Cyclo-Olefin-Copolymer (COC) blister film base and has the following performance characteristics and construction specifications:
High moisture barrier thermoformable material
COC-COEX and COC-laminates have an adjustable barrier to water vapor transmission and can be customized with a standard, medium or high barrier
Various gauges for moisture barrier optimization
Same machinability as PVC, but contains no Chlor or other halogens (entirely environmentally friendly olefinic material)
Excellent sealability with aluminum lidding material using PP or PVC heatseal lacquer
Highly transparent; also offered in opaque
High rigidity
Higher yield compare to PVC/PVDC and PVC/CTFE
Anti-counterfeiting packaging solutions with N'Crypt, visit
www.n-crypt.info
All laminates are listed in our DMF and correspond to FDA (Food and Drug Administration) and EP (European Pharmacopea) requirements.
www.alcalpackaging.com
PS (polystyrene)
PS is perfectly suitable for thermoforming but its high water-vapor permeability does not permit its use as a blister material for pharmaceutical purposes.
Coldform film (biaxally orientated polyamide (OPA), aluminum and PVC)
OPA-ALU-PVC (nylon-ALU-PVC), makes it possible to almost entirely eliminate water-vapor permeability. Also because of the high share of aluminum in this laminate, recycling of this material has become feasible, particularly because most lidding materials also consist of aluminum. Enormous efforts are being made to replace PVC with PP in such laminates in order to comply with environmental standards. Like other laminates containing aluminum, the OPA-aluminum-PVC laminate is cold formed instead of being thermoformed. The cost/m2 of this is equivalent to PVDC-coated PVC. Cold forming, however, requires more packaging material than thermoformed plastic film for packaging the same number and the same size of tablet or capsules.
Normally the permeability of plastic forming films increases with rising temperature. This is not true for aluminum formed packaging. Forming plastic film also causes a noticeable reduction in the thickness of the material. However when comparing the water-vapor transmission rates of the base material with that of the finished package there is not always a direct relationship between the thickness of the film and the water-vapor barrier effect.
Material Water Vapor Transmission Rate* Cost / square metre
PVC 3.1 $0.80
PVC/PVDC 40 gsm 0.75 $1.44
Triplex 0.45 $4.30
Aclar (Suprex 900) 0.23 $8.80
Aclar (Ultrex 2000) 0.12 $12.00
OPA/ALU/PVC (cold form) zero transmission $5.00
Lidding Material
The lidding material consists of support material eg aluminum that has a printed primer on one side and a sealing agent eg a heat-sealing lacquer on the other side. The sealing agent side faces the product and the forming films.
Lidding Material
After the tablets or capsules have been properly fed to the preformed support materials the lidding material is sealed onto the support material. Temperatures for this can range from 140-300°C. There are two sealing techniques: intermittent sealing with sealing plates and continuous sealing with sealing rollers. Intermittent sealing machines are operated at lower sealing temperatures than are continuous sealing machines. Intermittent sealing machines also have a longer sealing time.
An essential component of lidding material is the sealing coating. The side of the lidding material that faces the product and the forming film must be provided with a coating material suitable for heat sealing. This is usually accomplished by means of a heat sealing lacquer which must comply with FDA standards and must precisely match the respective forming films. Precisely match means that with predetermined sealing parameter, a permanent sealing effect between the lidding material and the forming film must be guaranteed under any climatic conditions. An additional requirement is that the sealing strength must fall within a predetermined tolerance.
Hard Aluminium
Hard Aluminum is the push through lidding material that is most widely used in Europe. The foil usually has a thickness of about 25 micron. However this may in time be reduced to 15 micron. The hardness of the aluminum facilitates push through opening. Usually only the print-primer side features a printed design, but occasionally the side with the heat-sealing lacquer can also be printed. A double coat of heat-sealing lacquer (a heat sealing primer and the actual heat-sealing lacquer) has become the standard for lidding materials.
The heat-sealing primer ensures optimum adhesion of the heat-sealing lacquer to the aluminum foil. Then the heat-sealing lacquer can be perfectly matched to the formed films. If the heat sealing primers are colored then the heat-sealing lacquer applied over the primer can protect the packaged product from coming into contact with the pigments. If additional printing is required on the side of the heat sealing lacquer, the only alternative is to apply two coats of the lacquer. This is necessary because the printing inks must be between the heat-sealing primer and the actual heat-sealing lacquer.
Soft Aluminum
This is frequently used for child-proof push-thru foils. With the exception of the type of aluminum used, the structure of this lidding material corresponds to that of hard aluminum. The softness and thickness of this type of aluminum help prevent children from pushing tablets through it. The lidding material is also provided with a perforation along the sealed seams to prevent the lidding material from being peeled off the form film in one piece.
Paper-Aluminum
For a combination of paper and aluminum the weight of the paper amounts to 40-50g/m 2. In the USA the thickness of the aluminum is greater than in Europe. The reason for this is that in Europe this lidding material is used for childproof push-thru packages. Therefore the aluminum foil is relatively thin. In the USA, this type of material is used as a peel-off foil and for effective peeling the aluminum foil must be relatively thick. Printing can take place directly on to the paper surface.
Paper-PET-Aluminium
Lidding material made of a paper-polyester-aluminum laminate is often called peel-off-push-thru foil. This kind of material is used predominantly in the USA and is virtually unknown in Europe. The concept is to first peel off the paper-PET laminate from the aluminum and then the tablet is pushed through the aluminum.
Requirements for Lidding Components
The print primer should meet the following requirements: It must withstand sealing temperatures as high as 300°C without showing discoloration or tackiness (blocking). It should offer sufficient resistance to abrasion and be a substrate to which printing inks can adhere strongly enough to withstand the peeling force of adhesive tapes. Finally the print primer must comply with FDA recommendations.
Similarly, printing inks must withstand sealing temperatures as high as 300°C without showing any discoloration or tackiness (blocking). The adhesion of the printing inks to the print primer must offer sufficient resistance to abrasion and to the peeling force of adhesive tapes and the inks must comply with FDA recommendations.
The basic lidding material must meet requirements for elasticity or inelasticity specific to the type of machine used. It must guarantee water-vapor transmission rate that is at least as low as that of the forming films and it must be suitable for the type of opening appropriate to the package eg. push-thru or peel-off.
The heat-sealing coat must be compatible with the plastic material of the form films and it must ensure constant sealing for any given sealing parameter. The sealing strength must be suitable for push-thru or peel-off opening and of course it must comply with FDA recommendations.
Eye Marks
The eye marks must be carefully adjusted to the type of machine used. If the machine is controlled by a feed mechanism, the eye marks must have extremely close tolerances. The total deviation across a distance of 1000mm must not exceed +/- 0.4mm. If the machine is controlled by a straightening mechanism that carries a roller with the lidding material, the distances between the eye marks are deliberately printed in the negative range because the lidding material is stretched to correspond to the speed of the machine.
