Empaquetado para cuidado de la salud
Mejorando y protegiendo los productos para el cuidado de la salud con soluciones de empaquetado con polímeros y desecantes
To maintain potency, stability, and shelf life, pharmaceuticals and healthcare products often require highly protective and active packaging. Clariant designs and manufactures proven and innovative solutions so critical healthcare industries can protect their products from moisture and oxygen. Our solutions protect:
- Pharmaceuticals (Ethical & OTC)
- Nutraceuticals and health supplements
- Diagnostics and medical devices
Clariant Healthcare Packaging is specialized in moisture, oxygen and odor control technologies, as well as in primary plastic packaging. Products are available in myriad sorption options to address various applications and in a wide range of configurations:
- Dropped-In: canisters, capsules, packets & bags
- Integrated: desiccant stoppers and closures, tubes, and desiccant washers
- Embedded: Advanced Desiccant Polymer (ADP®), diagnostic vials, and Oxy-Guard®Barrier Bottles.
Our plants are ISO 15378 GMP certified and we offer customer-focused services and technical support, a global operational footprint, and innovation and development capabilities.
Healthcare Packaging Brochure
Protective Packaging Solutions
Many healthcare products are subject to degradation, quality issues, and shelf-life reduction due to hydrolysis and oxidation. Thus, different types of active protection are required to address the most pressing stability issues.
Protection from Moisture: moisture is usually the primary pathway to degradation for pharmaceuticals, nutraceuticals and diagnostics. Explore more here.
Protection from Oxygen: Oxidation of drugs and nutraceuticals is a common occurrence and can be addressed with active and passive technologies. Explore more here.
Protection from Odors: Undesired odors can result from drugs and associated chemical compounds, gas degradants, and naturally from herbals and health supplements.
Explore the Web site for more information or contact a Clariant expert to discuss your application. Contact us.
Protecting Healthcare Packaging Applications
Before healthcare products keep people safe, it’s necessary to keep the products themselves safe! Whether oral solid dosage pharmaceuticals, drug delivery systems or diagnostic and medical devices, many healthcare products are susceptible to degradation and stability issues.
- Pharmaceuticals: Moisture and oxygen can cause physical and chemical degradation and stability issues of oral solid dosage (OSD) and other dosage forms over shelf life.
- Inhalation: Humidity conditions inside Dry Powder (DPI) Inhalers and Metered Dose Inhalers (MDI) can adversely affect proper deposition of drugs.
- Nutraceuticals/Health Supplements: Like OSD pharmaceuticals, dietary supplements, effervescent tablets and powdered sports nutrition can be highly susceptible to moisture degradation.
- Probiotics:Probiotics and prebiotics are extremely sensitive to moisture and oxygen, requiring special packaging to maintain culture counts.
- Diagnostics: The accuracy of IVDs and molecular diagnostics is dependent on protecting sensitive reagents and strips from reaction with moisture.
Explore the Web site for more information or contact a Clariant expert to discuss your application.
Pharmaceuticals
Protecting Pharmaceuticals from Moisture & Oxygen
Patient health often depends on the effectiveness of their medications and the avoidance of changes in drug properties due to degradation prior to expiry.
- Physical degradation of a drug includes change in appearance, organoleptic properties, hardness, brittleness and particle size.
- Chemical degradation occurs when there is a change in the chemical nature of the drug as chemical compounds separate. As pharmaceuticals chemically degrade, by-products or impurities are formed that can both affect the efficacy of the drug and cause adverse effects. Also, potency levels can reduce over time. The United States Pharmacopeia requires that drug products regain 90 percent of their potency at expiration.
Many drugs are susceptible to hydrolytic degradation due to their hygroscopicity, or tendency to absorb moisture from their environment.
- Esters and amides, as well as lactones, are quite commonly used in pharmaceuticals, and are particularly susceptible to moisture degradation.
- Disintegrants and/or excipients are commonly used in pharmaceutical products to facilitate solubility and bioavailability, affect dissolution rates and absorption, or provide additional therapeutic or delivery-system benefit.
Consequently, these ingredients can also affect drug stability due to their interaction with moisture.
Oxidative degradation of pharmaceuticals can also be an issue. Auto-oxidation of pharmaceuticals occurs when the drug product is exposed to open-air oxygen. The removal or addition of an electropositive atom, radical or electron contributes to chemical degradation.
Degradants are often identified during forced degradation studies, helping to identify stability issues during the drug development process. Ultimately, Accelerated Stability Assessment Programs (ASAP) and ICH-prescribed accelerated stability studies are conducted, during which the optimum packaging configuration is identified to product drug products from moisture and oxygen during the desired shelf life.
Desiccants, oxygen scavengers, oxygen barrier materials, and other active packaging solutions are used to ensure stability through shelf life. Desiccants like silica gel and molecular sieve effectively control the atmosphere inside the package by reducing and maintaining a low Relative Humidity inside the bottle, while adsorbing moisture that gains ingress via moisture vapor transmission during shelf life. Oxygen protection is also important and can include oxygen scavengers and Oxy-Guard™ barrier bottles to avoid pharmaceutical oxidation.
For more information about moisture protection solutions, visit our Product Page. For oxygen protection, visit directly our product pages on PHARMAKEEP® or Oxy-Guard® Barrier Bottle.
Health Supplements & Probiotics
Protecting Health Supplements & Probiotics from Moisture & Oxygen
Nutraceuticals in a variety of dosage forms like health supplements, vitamins, and probiotics are susceptible to physical and chemical degradation, affecting their quality and shelf life.
- Dietary supplements, like oral solid dosage pharmaceuticals, are subject to deliquescence and chemical hydrolysis, affecting physical qualities and/or reducing the amount of active ingredients over time. In the presence of high humidity, water-soluble supplements and effervescent tablets can begin to dissolve or effervesce, rendering them impossible for a consumer to consume.
- Probiotics are dehydrated rendering them dormant until they reach the moist environment inside the body. Thus, probiotic supplements are naturally very hygroscopic with an affinity to absorb available moisture. Consideration of moisture as well as oxygen protection are key to maintain culture counts.
Desiccants, oxygen scavengers, tubes & desiccant stoppers, oxygen barrier materials, and other active packaging solutions are used to ensure stability through shelf life. Desiccants like silica gel and molecular sieve effectively control the atmosphere inside the package by reducing and maintaining a low Relative Humidity inside the bottle, while adsorbing moisture that gains ingress via moisture vapor transmission during shelf life. Oxygen protection is also important and can include oxygen scavengers and Oxy-Guard™ barrier bottles to avoid pharmaceutical oxidation.
For more information about moisture protection solutions, visit our Product Page. For oxygen protection, visit directly our product pages on PHARMAKEEP® or Oxy-Guard® Barrier Bottle.
Diagnostics
Protecting IVD & Medical Devices from Moisture
Mositure can damage in vitro diagnostics (IVDs) and medical devices in a number of ways. Excessive moisture can:
- influence the reliability of rapid tests by degrading their reagents and/or precious metals
- effect the aging and migration of adhesives that are used in the construction of lateral-flow assays
- effect the membrane components water interferes via hydrogen bond protein-membrane binding.
Point-of-care tests are susceptible to moisture damage. Pregnancy tests can be altered if not protected from moisture. Glucose test strips are particularly vulnerable to humidity, especially when packaged in bulk quantities that are utilized multiple times per day by diabetics.
Molecular diagnostic cartridges and assays such as ELISA kits often contain special reagents that need to be protected from moisture prior to use in the field or clinical laboratory.
Medical devices are also moisture sensitive, many of which are combination devices like drug-eluting heart stents.
Desiccants and embedded desiccant packaging systems are used to ensure stability through shelf life. Desiccants like silica gel and molecular sieve effectively control the atmosphere inside the package by reducing and maintaining a low Relative Humidity inside the package, while adsorbing moisture that gains ingress via moisture vapor transmission during shelf life.
For more information about moisture protection solutions, visit our Product Page. For oxygen protection, visit directly our product pages on PHARMAKEEP® or Oxy-Guard® Barrier Bottle.
Inhalation
Moisture Control for Inhalation Pharmaceuticals
Inhalation is a very common method of drug delivery and has been used for a long time. Whether a pressurized Metered Dose Inhaler (pMDI), Dry Powder Inhaler (DPI) or Nebulizer, deposition of the medication into the lungs is key to its effectiveness.
Protection from Oxygen
Dry Powders, often micronized drugs blended with larger carrier particles, are especially sensitive to extremes in humidity conditions which affects the ability of the powder to optimally spread and settle inside the patient’s lungs. Both high humidity and overly dry conditions can affect powder flow and deposition of drug powders.
- High humidity conditions increase cohesive and adhesive forces of the particles causing undesirable agglomeration.
- Excessive dryness can increase the electrostatic charge of the particles can cause particle aggregation
Metered Dose Inhalers can also be affected by moisture, particularly physical stability of the pMDI formulation. For example, propellants can be significantly depressed by an increase in water level.
Equilibrium stabilizers and desiccants are often used to control relative humidity inside Inhaler packaging in order to maintain a specific RH level (i.e. 20-30%) or if needed in a very dry RH condition and ensure premium efficiency of the powdered drug.
For more information about moisture protection solutions, visit our Product Page. For oxygen protection, visit directly our product pages on PHARMAKEEP® or Oxy-Guard® Barrier Bottle.
Innovation & Customer Support
Clariant Healthcare Packaging offers customers a full set of services to assist customers develop, configure, validate and implement the optimal packaging solution to protect and dispense their drug.
- Product Development: Whether tweaking a standard product or design of a customized packaging system, Clariant has a full product development team that will quickly and efficiently engineer a solution. Following an ISO-certified stage gate process, Clariant works with customers to ideate, design, and qualify (FMEA, IQ, OQ, PQ) packaging products that will best serve their protective packaging needs.
- Innovation: Clariant is a leader in technology development and constantly researching materials and designs to address the increasing drug stability challenges. We often hold innovation workshops in collaboration with customers to find the right solution together.
- Predictive modelling & simulation: With our proprietary Stablus™ Program, Clariant works directly with customers to help calculate the optimal packaging configuration, desiccant dosage, or oxygen scavenger need for a particular application.
- Insert machine compatibility: Clariant’s Compatilus™ Program ensures full compatibility with various inserters available from key equipment manufacturers.
Operational & Regulatory Excellence
Operational & Regulatory Excellence
To ensure product quality, maintain a superior service level, and compliance with all relevant regulations, Clariant Healthcare Packaging follows several operations excellence methodologies and strict product stewardship oversight across five production sites.
- 6 Sigma
- 6 S (Safety, Sort, Straighten, Shine, Standardize, Sustain)
- ISO 15378 - ISO 9001 - ISO 14001 certified plants
- OHSAS 18001 certified
- Business Continuity Planning (BCP)
- FDA Compliance (21 CFR) certificates available
- EU Compliance (N°10/2011) certificates available
- USP <670> compliant materials670>
- Drug Master Files (DMFs)
- Change Control Procedures in place
Clariant Healthcare Packaging is an international organization with manufacturing facilities and sales offices worldwide. Having production at multiple sites around the world allows for customer supply chain optimization and product supply contingencies. Our global reach also provides customers with regionally located product experts ready to meet in person and respond to urgent needs.
France Sales Office
Choisy le Roi, France6 rue Louise MichelBP 20794 603 Choisy le RoiFrance
Tel.: +33 1 41 76 20 00Fax: +33 1 41 76 20 57
France Plant
Romorantin, FranceUsine de RomorantinZAC de la Grange41 200 Romorantin
Tel: +33 254 952 300Fax: +33 254 952 301
United Kingdom Sales Office
United Kingdom3 Drake MewsGadbrook ParkNorthwichCheshireCW9 7XFUnited Kingdom
Tel.: +44 1606 350 384Fax: +44 1606 350 384
South East Asia and Australia Office
South East Asia and Australia Office1 International Business Park#08-01-04The SynergySingapore 609917
+65 6643 1138
China Sales Office
Shanghai, ChinaNo. 2, Lane 168 Linhong RoadChangning District200335 ShanghaiChina
Tel: 0086-21-2248-3000(General line): 0086-21-2248-3421(Direct line): 0086-138-1766-6319Fax: 0086-21-2248-3496
China Plants
Changshu, China18 Zhujiang Road,Southeast Development ZoneChangshu 215500China
Tel: +86 512 523 587 89
Fax: +86 512 523 587 19
India Sales Office
Mumbai, IndiaClariant Medical Specialties India LtdReliable Tech ParkOff Thane-Belapur RoadAiroli, Navi Mumbai – 4007088Maharashtra
Tel: +91 22 7125 1000
Dongguan, China
Block No. 4,
Tang Hong Industrial Zone, Shijie Town,
Dongguan 523307
ChinaTel: +86 769 86302638
Fax: +86 769 86302618
India Plant
Cuddalore, Tamil NaduClariant Medical Specialties India LtdSurvey No.170/5, 170/3 & 169/1Kudikadu, SIPCOT PostCuddalore - 607 005Tamil Nadu
Tel : +91 4142 3958250
Unites States Sales Office
California, USA926 S. 8th St.PO Box 610Colton, CA 92324United States
Tel.: +1 855 628 1601
Fax: +1 909 825 6271
Unites States Plant
New Mexico, USARio Grande Industrial Park101 Christine DriveBelen, NM 87002United States
Tel: +1 505 244 7100Fax: +1 505 244 7121
| octubre 31, 2019 |
Clariant completes the sale of its Healthcare Packaging businessClariant, a focused and innovative specialty chemical company, today announced the completion of the sale of its Healthcare Packaging business to a newly-formed investment of Arsenal Capital Partners, the signing of which was announced on July 22, 2019. The sale was closed on October 31, 2019. more |
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| julio 24, 2019 |
Clariant Adds Pharmaceutical Desiccant Packet Production Capability in Cuddalore, IndiaThe Clariant Healthcare Packaging business unit is now producing desiccant packets at its plant in Cuddalore, Tamil Nadu, India. The addition expands the range of desiccant products immediately available to customers in the region and increases global capacity. more |
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