Flexible formable films
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FOR MEDICAL DEVICE MANUFACTURERS • Form Fill Seal Packaging Lines New PA-PE film range designed and produced by the Sterimed Group Flexible formable films www.sterimed.fr
Transcript of Flexible formable films
FOR MEDICAL DEVICE MANUFACTURERS
• Form Fill Seal Packaging Lines
New PA-PE film range
designed and produced
by the Sterimed Group
Flexible formablefilms
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Resistant and SafeEthyForm™ XPA films’ biocompatible chemistry, designed for medical applications, is very stable over time as well as during sterilization processes. Combined with excellent performance in standard mechanical tests such as puncture, stretch, or tensile, EthyForm™ XPA films are both resistant and safe.
100% designed for medical applications
EthyForm™ XPA films are manufactured in ISO Class 8 clean rooms by medical manufacturing qualified staff in an ISO 9001 certified site. EthyForm™ XPA films are fully compliant to ISO 11607-1 standards.
Excellent sealing and aseptic opening
EthyForm™ XPA films sealing layer technology offers both Seal Strength levels fitting each application requirement with uncompromised sealing integrity and excellent aseptic opening. This proprietary technology allows large operating windows to support higher productivity.
Optimized and qualified to seal to Polybond™ and
Ethypel™ top websSTERIMED offers you a unique expertise for both top and bottom webs: EthyForm™ XPA, designed by our Green Sail teams in China and Ethypel™/Polybond™ are designed to match. Consolidated qualification information will help you efficiently build your packaging validation documentation.
The new EthyForm™ XPA films are multilayer cast coextruded PA-PE formable films. Ethyform™ XPA films are designed to be used on Form Fill Seal packaging lines as bottom film for the packaging of sterilized medical devices.
New PA-PE film range designed and produced by the Sterimed Group
ETHYFORM™ XPA WIDE RANGEEthyForm™ XPA films address various medical devices profiles with a wide range of available thicknesses, from 60 µm to 200 µm, from shallow to deep draw, and for light or heavier medical devices.
R = Reinforced
ST = Surface Treated
HP/CP/SP/GP = Coated
TOP TO BOTTOM WEB SOLUTIONS
330
320300280260
240
220
200
180
160
140
120Light Weight / Small Size PACK STYLE Heavy Weight / Large Size MECHANICAL
STRENGTH
Flexible formable
Flexible formable
SBS 2
SEALSTRENGTH
(cN/15 mm)
5
1
32
67
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OUR QUALIFIED COMBINATIONS INCLUDE:
1 - Polybond RHP 117 gsm to EthyForm XPA 200 µm
2 - Polybond BGP 90 gsm to EthyForm XPA 200 µm
3 - Polybond RHP 85 gsm to EthyForm XPA 130 µm
4 - Polybond RCP 83 gsm to EthyForm XPA 130 µm
5 - Polybond RST 80 gsm to EthyForm XPA 120 µm
6 - Ethypel Classic GP 62 gsm to EthyForm XPA 80 µm
7 - Ethypel Performance 60 gsm to EthyForm XPA 90 µm
EXTERNAL SIDEPA-PE-PA layers construction for resistance, flexibility, and excellent capabilities for thermoforming (deep draw)
SEALING SIDEPE and proprietary heat reactive PE layers construction for sealing performance
TOP TO BOTTOM WEBS SOLUTIONS WITH ETHYFORM™ XPA
STERIMED created qualified combinations to widely cover the medical devices flexible packaging needs spectrum, leveraging its Polybond™ and Ethypel™ top web technologies and its new films range EthyForm™ XPA formable films.
ETHYFORM™ XPArange
Thickness Tensile Strength Elongation Draw recommendation*
µm / mil kN/m % mm / inch
ASTM F2251 ASTM D 882 ASTM D 882 -
ETHYFORM XPA 60µm 60 / 2.36 2,4 530 < 12 / 0.47
ETHYFORM XPA 90µm 90 / 3.54 3,2 580 18-20 / 0.71-0.79
ETHYFORM XPA 120µm 120 / 4.72 3,9 620 24-26 / 0.94-1.02
ETHYFORM XPA 130µm 130 / 5.12 4,1 630 28-30 / 1.10-1.18
ETHYFORM XPA 200µm 200 / 7.87 5,8 700 36-50 / 1.42-1.97
< 100 µm – Shallow draw 100-150 µm – Medium draw 150-200 µm – Deep draw
* Indicative values only, maximum draw may be higher depending on process parameters and equipment.
MEDICAL DEVICE MANUFACTURERS
CONVERTERS
PATIENT CARE FACILITIES
NOVEMBER 2021
SALES OFFICES
Compliance: Our products comply with strict regulations and standards, ensuring maximum protection for patients and hospital staff: ISO 11607-1:2019
STERIMED, your Infection Control Partner • Largest range of sterilization packaging substrates in the world• Sales in more than 70 countries• Packaging education programmes for medical device industry and hospital staff
Seminars & trainingSTERIMED has created the « Shared, a Sterimed Experience » program to create an opportunity to share the knowledge on medical devices packaging and hospital sterilization with our customers.We aim to create a sustainable and durable relationship with our com-munity, and through seminars, webinars, information and experience sharing, improve patients safety together.
www.sharedbysterimed.com
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STERIMED, complete solutions for:
STERIMED™, ETHYPEL™, PROPYPEL™ , STERISHEET™, POLYBOND™, ETHYFLEX™,
ETHYFORM™, CRYPTOPAK™, STERIWEB™, STERI FEUILLE™, STERIREEL™, 斯迪迈™, 舒卫安™, 蒸洁安™, Стеримед™, Этипель™, Пропипель™ are all brands of STERIMED.
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ASIA-PACIFIC• STERIMED (Suzhou) Co. LtdWujiang Economic & Technological Development ZoneNo. 1868, Guangming Road, Suzhou, Jiangsu, 215200, CHINAPhone: +86 (0)512 6316 0176Fax: +86 (0)512 6316 [email protected]
AMERICAS•• STERIMED Inc1301 Charleston - Regional Parkway Charleston - 29492 SC South Carolina - UNITED STATESPhone: +1 843 388 80 80 Fax: +1 843 388 80 70 [email protected]
• EEE MexicoGuillermo Barroso No. 11-1 IndustrialLas Armas C.P. 54080. TlalnepantlaEstado de México, MÉXICOPhone: +52 55 2626 5001 [email protected]
EUROPE, AFRICA & THE MIDDLE EAST• STERIMED SROCT Park - Evropska 866 Modrice, 664 42 - CZECH REPUBLICPhone: +420 547 424 934 [email protected]
• STERIMED SAS47/49 av. Edouard Vaillant 92100 Boulogne-Billancourt FRANCEPhone: +33(0)1 77 37 35 28 [email protected]
Safety for your medical devices100% dedicated healthcare premises• Quality management system developed for healthcare packaging
operations• Staff education and mindset purely focused on medical device
industry requirements• Minimized risk of cross contamination thanks to fully specialized healthcare production sites• ISO 13485 certified production sitesIntegrated operations for best possible value propositions based on your packaging needs.
Environmental performance• Porous products manufactured from renewable sustainable
recyclable raw materials• ISO 50001 certification• Directly from base web manufacturing facility to your operations,
without need for third party converting
