Mediprene 500M 系列

The Mediprene 500M range encompasses our original medical TPE grades. They are available in hardnesses from 0 Shore A to 62 Shore D. With translucent and transparent grades, they are also easy to colour.
Mediprene grades are sterilizable with gamma, EtO and steam and representative grades have passed cytotoxicity tests according to ISO 10993-5 and biocompatibility tests according to ISO 10993-10 (Intracutaneous Reactivity), ISO 10993-11 (Acute Systemic Toxicity) and USP Class VI. Mediprene TPEs have proven to be a strong alternative as replacement to PVC; they are completely synthetic and latex free thereby minimizing allergy risks.
The right TPE formulation is the key to a safe and successful medical product. When a standard formulation does not meet the needs of a unique application, we will formulate a custom solution.

Special Features
• Flexibility and elasticity
• 0 Shore A to 62 Shore D
• Translucent grades
• Soft-touch appeal
• Excellent resistance to many fluids used in the healthcare environment
• PVC, silicone & latex free
• Adhesion to PP or PE in 2K applications
• Easy to process with short cycle times
• Sterilizable with autoclave, EtO and Gamma irradiation
• ISO 10993-5 and USP Class VI compliant
• Production site accredited to ISO 9001, 14001 and 13485

Applications
• Soft-touch grips
• Resealable membranes
• Airway management
• Face masks
• Connectors
• Medical packaging
• Wound care
For further information about our Mediprene TPE compounds please contact mediprene@hexpolTPE.com

INTRODUCTION

Mediprene thermoplastic elastomers (TPEs) are suitable for a wide variety of uses in the medical and pharmaceutical market and new applications are being developed all the time. Mediprene compounds combine the performance of vulcanised rubbers with the processing properties of thermoplastics, delivering sophisticated design opportunities through a wide and flexible range of products.

Thermal and mechanical properties can be designed into the formulations and Mediprene compounds are fully recyclable and thus fulfil environmental requirements. Mediprene thermoplastic elastomers have proven to be strong alternatives as replacement for PVC. They are completely synthetic and latex free thereby minimizing allergy risks.

The right TPE formulation is the key to a safe and successful medical product. When a standard formulation does not meet the needs of a unique application, we will apply our expertise in formulating a custom solution. In this guide we show typical properties for our most common grades, these tables do not list all available properties and materials.

Please use this guide as an introduction to our Mediprene 500M standard series and contact us to discuss your specific requirements.

RAW MATERIAL SELECTION

In order to be called Mediprene, the raw material constituents of the compound must not only comply with food contact norms like FDA 21CFR and Commission Regulation (EU) No 10/2011 but also have medical approvals, assuring their biocompatibility. We have introduced a clear policy for the selection of raw materials for Mediprene compounds, typically consisting of; SEBS rubber, paraffinic oil and polypropylene:

• The rubber should be selected from a series of rubbers where representative grades have passed USP Class VI

• The paraffinic oil should be a medicinal white oil, complying with the European Pharmacopoeia for light liquid paraffin

• The polypropylene should be a medical grade that has passed USP Class VI

Originating from medical raw materials with high biocompatibility status and compounded under clean conditions, Mediprene TPEs are the material of choice for medical customers who want to maximize the probability that their devices will pass relevant medical tests.

REGULATORY COMPLIANCE

The basis for a successful outcome in medical tests is raw material selection, only allowing raw materials that, from a medical point of view, are highly qualified. The raw materials are then compounded together under clean conditions, with high consistency.

To further assure the customer, representative grades from the Mediprene standard series (500200M and 520620M, respectively) have been tested by NAMSA in the USA for cytotoxicity according to USP/ISO 10993-5 and for biocompatibility according to ISO 10993-4 (Hemolysis), ISO 10993-10 (Intracutaneous Reactivity and Sensitization), ISO 10993-11 (Acute Systemic Toxicity) and USP Class VI. All materials that were tested successfully passed (copies of the certificates are available on request).

The other compounds in the Mediprene standard series with hardness values between 20 ShA (500200M) and 62 ShD (520620M) consist of the same raw materials and would therfore probably pass if tested. Note that there is an overlap between some tests in USP Class VI and tests described in parts of ISO 10993, meaning that the material is highly likely to pass parts of ISO 10993 when having passed USP Class VI. However, be aware that it is always the responsibility of the supplier of the finished product to perform relevant tests to ensure that the complete device fulfils the compliance criteria that have been set up for the product.

REGULATORY INFORMATION

The purpose of the next few pages is to briefly describe the tests in the United States Pharmacopoeia (USP) and ISO 10993 that have been done on representative grades from the Mediprene standard series. We also include comments on compliance with European Pharmacopoeia (EP) monographs.

CYTOTOXICITY TESTS – USPAND ISO 10993-5

The elution test, as described both in monograph 87 of the United States Pharmacopoeia and in part 5 of ISO 10993, includes the following steps:

• The sample material is extracted with sodium chloride solution or serum-free mammalian cell culture medium under well-defined conditions

• A cell culture (L-929 mammalian fibroblast cells) is exposed to the sample extract as well as a positive and a negative control under welldefined conditions

• The cells are checked (appearance, cell lysis etc) after 48 hours and the response to the sample extract is judged with help of the guidelines in USPas none, slight, mild, moderate or severe (grades 0-4).

The requirements of the test according to USPare met if the response to the sample extract is not greater than 2 (mildly reactive). ISO 10993-5 does not contain a pass/fail criterium for this test.

BIOCOMPATIBILITY TESTS ACCORDING TO USP (USP CLASS VI)

Biological reactivity tests, in vivo, are described in USP. Six plastic classes are defined – USP Class I-VI, among which USP Class VI requires the most exhaustive testing. USP Class VI contains the following main tests:

• Systemic injection test

• Intracutaneous test

• Implantation test

Except for the implantation test, tests are carried out using extracts of the material to be tested. These extracts are prepared with differed solvents under well-specified conditions (surface area, temperature, time etc). For the implantation test small sample strips (minimum 10x1 mm) are used.

On the following pages is a brief description of each test and its purpose.

SYSTEMIC INJECTION TEST

PURPOSE : To determine the biological response of mice to the material by injection of specific extracts prepared from samples of the material.

TEST : Extracts of the sample material in sodium chloride solution, 1 in 20 solution of alcohol in sodium chloride solution, polyethylene glycol 400 and vegetable oil, respectively, as well as blanks are injected into albino mice. The mice are then observed at different time intervals up to 72 hours after injection. If none of the animals treated with the extract of the material shows a significantly greater biological reactivity than the animals treated with the blank, the material has passed the test.

INTRACUTANEOUS TEST

PURPOSE : To determine the local biological response of rabbits to the material by injection of specific extracts prepared from samples of the material.

TEST : Extracts of the sample material in sodium chloride solution, 1 in 20 solution of alcohol in sodium chloride solution, polyethylene glycol 400 and vegetable oil, respectively, as well as blanks are injected into albino rabbits intracutaneously. Each extract is injected into two animals on one side of the spinal column and the blank on the opposite side. The injection sites are examined for evidence of tissue reactions such as erythema, edema and necroses at different time intervals up to 72 hours after injection. The observations for both extract and blank sites are rated on a numerical scale based on guidelines given in USPevery time the sites are inspected. After 72 hours the overall mean score for each sample and each corresponding blank is calculated. If the difference in mean score between sample and blank is 1.0 or less the material extracted has passed the test.

IMPLANTATION TEST

PURPOSE : To evaluate the reaction of living tissue to the material by the implantation of a sample into the tissue of a rabbit.

TEST: The paravertebral muscle of two rabbits is implanted – each by four strips of the sample material and two strips of USP High-Density Polyethylene RS. The animals are kept minimum 120 hours and are then sacrificed by an overdose of anaesthetic agent or other suitable agent. The tissue is cut and the tissue portion surrounding each strip is examined for hemorrhage, necrosis, discolorations, infections and encapsulation. Encapsulation is determined by measuring the width of the capsule and rated on a numerical scale based on the guidelines given in USP. The difference between the average scores for the sample and the control are calculated. If the difference is 1.0 or less the material has passed the test, alternatively if the difference in sample and control mean scores for more than one of the implant sites is less than or equal to 1 for any implanted animal.

Please note that, even though representative Mediprene grades have passed these implantation tests. We do not supply thermoplastic elastomers for implants.

EUROPEAN PHARMACOPOEIA (EP)

The European Pharmacopoeia contains monographs and other texts that are designed to be appropriate to the needs of regulatory authorities, people engaged in quality control and manufacturers of starting materials and medicinal products.

We have successfully tailor-made Mediprene grades that have passed selected monographs in chapter 3.1 of the European Pharmacopoeia, dealing with materials used for the manufacture of containers.

Please contact us for advice if compliance with a special EP monograph is needed.

FORMULATION STABILITY, CHANGE, NOTIFICATION AND AVAILABILITY

We are well aware of the severe consequences that most medical customers face when a formulation is changed. Therefore, Mediprene formulations are never changed unless one or more of its constituents cease to exist.

In case a formulation from the Mediprene standard series has to be changed due to a change or discontinuation of one or more raw materials, HEXPOL TPE will notify the customer. A volume of the unchanged compound corresponding to the quarterly updated two year forecast from the customer can then be made available to allow the customer to qualify a replacement compound.*

*With exception of Force Majeur situations.

CLEAN LINE PRODUCTION & QUALITY

Mediprene thermoplastic elastomers are produced with modern production equipment, designed for easy cleaning and with traceability and documentation based on the requirements of ISO 13485:2012 (medical devices). To achieve the high cleanliness that every medical customer has the right to expect, special measures are taken, such as:

• Thorough and well documented cleandown of the compounding line before running Mediprene compounds

• Closed systems from ribbon blender to packaging

• Special precautions in the ribbon blender and packaging areas

• Operators wearing clean clothes, gloves and hairnet

Mediprene grades are all manufactured under strict quality control, ensuring product property consistency. Our site producing Mediprene compounds is accredited to ISO 9001, ISO 14001 and ISO 13485.

KEY PROPERTIES

• Flexibility and elasticity

• Transparent grades available

• Can be easily coloured in any shade

• Soft touch

• Excellent resistance to many fluids used in the health-care environment

• PVC, silicone and latex free

• Adhesion to PP or PE without modification in overmoulding and coextrusion

Processable with ordinary methods for thermoplastics processing, such as injection moulding and extrusion.

• Short cycle times

APPLICATION EXAMPLES

Mediprene thermoplastic elastomers can be used in various applications such as face masks, continence care products, connectors, IV systems, intubation equipment, seals, resealable membranes, drip chambers, wound care products, tubing, medical packaging and soft touch grips on medical devices. We are continuously working with our customers to develop new applications for Mediprene compounds.

STERILIZATION PERFORMANCE

Many medical devices are sterilized prior to use, sometimes several times during their lifetime. Therefore it is important that the materials used retain their properties after numerous sterilizations.

Representative Mediprene grades have been sterilized with the following methods:

• Steam/Autoclave

• Ethylene oxide (EtO)

• Gamma irradiation (25 kGy and 50 kGy)

Their properties have been evaluated before and after sterilization. This investigation shows that ethylene oxide sterilization is the most gentle sterilization method for Mediprene thermoplastic elastomers.

A SELECTION OF MEDIPRENE 500M STANDARD SERIES GRADES

PROCESSING

Mediprene compounds can be processed using conventional thermoplastic equipment for injection moulding, extrusion etc. Processing temperatures normally range from 180°C to 210°C. The compounds in the standard series are not hygroscopic and thus do not need predrying.

SERVICE TEMPERATURE RANGE : From  -50 to max +125°C (depending on hardness)

COLOURING RECOMMENDATIONS : For Mediprene compounds, polyolefin based masterbatch is recommended for colouring. Not to violate the high medical status of the Mediprene compound, the colour masterbatch should have passed USP Class VI or comparable tests.

WASTE DISPOSAL : All Mediprene grades are fully recyclable and, where possible, reprocessable during manufacturing. When burned, Mediprene compounds do not emit toxic fumes.

TPE复合物应用于注射器柱塞密封件

We have developed a range of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes. The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimize plunger movement for accurate dosage control and ease of injection.
Originating from medical raw materials with high biocompatibility status and compounded under clean conditions, Mediprene TPEs are the material of choice for medical customers who want to maximize the probability that their devices will pass relevant medical tests.

All Mediprene TPE Syringe Plunger Series compounds fulfil a strict raw material selection policy. The raw materials are food contact compliant (FDA 21CFR and Commission Regulation (EU) No 10/2011) and have a proven level of biocompatibility:

• The styrenic block copolymer has passed USP Class VI
• The paraffinic oil is a medicinal white oil complying with the EP for liquid paraffin and USP 24 for mineral oils
• The PP has passed the USP Class VI tests and meets the requirements in the EP Monograph 3.1.3 Polyolefins
• The components of the black masterbatch have passed USP Class VI or corresponding parts of ISO 10993

For further information about our Mediprene TPE compounds please contact mediprene@hexpolTPE.com

INTRODUCTION

We have developed a range of Mediprene thermoplastic elastomers (TPE) for plunger seals in single-use syringes.

The TPE seal, which is mounted on the end of the plunger, needs to provide a leakproof seal with the syringe barrel. As ease of use for the medical practitioner and patient comfort are also key requirements, the seal helps to optimize plunger movement for accurate dosage control and ease of injection.

The right TPE formulation is the key to a safe and successful medical product. When a standard formulation does not meet the needs of a unique application, we will apply our expertise in formulating a custom solution. In this guide we show typical properties for our most common grades, these tables do not list all available properties and materials.

Please use this guide as an introduction to our Mediprene 500M - syringe plunger seal series and contact us to discuss your specific requirements.

REGULATORY COMPLIANCE

All Mediprene TPE Syringe Plunger Series compounds fulfil a strict raw material selection policy. The raw materials are food contact compliant (FDA 21CFR and Commission Regulation (EU) No 10/2011) and have a proven level of biocompatibility:

- The styrenic block copolymer has passed USP Class VI

- The paraffinic oil is a medicinal white oil complying with the EP for liquid paraffin and USP 24 for mineral oils

- The polypropylene has passed the USP Class VI tests and meets the requirements in the EP Monograph 3.1.3 Polyolefins

- The components of the black masterbatch have passed USP Class VI or corresponding parts of ISO 10993

Note: Mediprene grades are not to be used in any devices or materials intended for implantation in the human body.

COLOURED COMPOUNDS

We offer these grades as translucent or coloured compounds.

The colour masterbatch supplier has been selected with care, ensuring that not only the pigments and carriers are compliant but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control, thereby fitting the Mediprene concept at our ISO 13485 accredited facilities.

A fully colour compounded TPE gives a perfectly dispersed, consistent colour with a correct and reproducible addition level. Mediprene colour compounds ensure colour reproducibility and deliver a compound ready for use, with no additional steps for the moulder or extrusion company.

TYPICAL GRADES

PROCESSING

The material has excellent processing characteristics and can be processed using standard thermoplastic fabricating methods, including injection moulding and extrusion.

Alongside their material advantages, because of the cost and speed at which they can be manufactured, Mediprene TPEs are being specified as an alternative to thermoset rubber. Fewer process steps, without the need for additional operations such as trimming means less energy is used and production is faster and more cost-efficient. TPEs have a lower specific gravity compared to several alternative materials, you can therefore not only create lighter-weight parts, but can also produce more parts per kilogram of material.

Service Temperature Range -50 to +125°C (unstressed material)

透明的TPE复合物，专为医疗应用设计

Mediprene 500M系列医疗应用TPE内包含数个透明规格，均是响应医疗市场上日益增加的透明复合材料需求而研发。
Mediprene TPE材料不含PVC、硅胶及乳胶等致敏原， 使其成为了PVC基材复合物的有效替代物。 硬度范围从30到90邵氏A，为设计提供更大自由。

特点：

• 高透明度
• 不含PVC、硅胶及乳胶
• 软触感
• 30-90 邵氏A
• 有配色和透明规格
• 生产现场符合ISO13485认证
• 能通过伽马射线，环氧乙烷（Eto）及蒸气消毒
• 在较广温度范围仍保持弹性
• 优越的密封性和粘附力

应用
对许多医疗设备而言，例如医疗面罩，可透过产品清晰监看病人这点甚为重要。透明TPE亦应用在生产医疗导管及牙科产品上。

有色及透明
医疗设备和制药包装中，颜色时常用于产品识别，以区分不同用途和尺寸的产品。
有各种鲜艳色彩可选的Mediprene复合物也给品牌所有者创造了增加产品附加值及创造视觉吸引力的手段。蓝色或绿色经常添加到高透或半透产品中，以掩饰由例如伽马射线消毒导致的黄变现象。
有色的透明复合物只采用医疗级别原材料生产而成。我们谨慎选择颜色母料供应商，不但确保色粉和载体均符合USP VI级或ISO 10993标准的部分要求，而且色母在对可追溯性、一致性和变更的严格控制下进行生产，从而使Mediprene概念跟我们的ISO 13485认证设施保持一致。

颜色持久度
预着色TPE复合物提供完美的分布一致的色彩，而且是正确并可重复添加的。Mediprene有色复合物确保色彩再现性，注塑或挤出的加工厂在使用时，无需额外的步骤。

INTRODUCTION

The Mediprene 500M range of TPEs for medical applications includes several transparent grades. These compounds were developed in response to an increasing interest in transparent compounds from the medical market.

Mediprene TPE materials are PVC, silicone and latex free, making them allergen free and a viable alternative to PVC based compounds. They offer hardnesses from 30 to 90 Shore A, allowing a wide degree of design freedom.

The right TPE formulation is the key to a safe and successful medical product. When a standard formulation does not meet the needs of a unique application, we will apply our expertise in formulating a custom solution. In this guide we show typical properties for our most common grades, these tables do not list all available properties and materials.

Please use this guide as an introduction to our Mediprene 500M transparent series and contact us to discuss your specific requirements.

KEY PROPERTIES

• Good transparency

• PVC, silicone and latex free

• Soft-touch appeal

• 30 to 90 Shore A

•Coloured, transparent grades

• Production site accredited to ISO 13485

• Sterilizable with gamma, ethylene oxide (EtO) and steam

• Flexibility over a broad temperature range

• Excellent sealing and adhesion

REGULATORY COMPLIANCE

All Mediprene Transparent TPE Series compounds fulfil a strict raw material selection policy. The raw materials are food contact compliant (FDA 21CFR and Commission Regulation (EU) No 10/2011) and have a proven level of biocompatibility:

- The styrenic block copolymer has passed USP Class VI

- The paraffinic oil is a medicinal white oil complying with the EP for liquid paraffin and USP 24 for mineral oils

- The polypropylene has passed the USP Class VI tests and meets the requirements in the EP Monograph 3.1.3 Polyolefins

Note: Mediprene grades are not to be used in any devices or materials intended for implantation in the human body.

TYPICAL APPLICATIONS

The ability to clearly see through a product to monitor the patient is an important feature for many medical applications such as face masks.

Mediprene Transparent TPEs can also be used in tubing and dental applications.

COLOURED & TRANSPARENT COMPOUNDS

In medical devices and pharmaceutical packaging colour is also often used functionally for product identification; to differentiate products with different uses or sizes. The vibrant colours achievable with coloured Mediprene TPE compounds allow brand owners to add value to their products and create visual appeal.

A blue or green colour is often used in medical transparent or translucent products to disguise the yellowing phenomena that can be caused by for example gamma sterilization.

The coloured transparent compounds are made from medical grade raw materials only. The colour masterbatch supplier has been selected with care, ensuring that not only the colorants and carriers are compliant with USP Class VI or corresponding parts of ISO 10993 but also that the masterbatches are manufactured under rigorous controls with regard to traceability, consistency and change control, thereby fitting the Mediprene concept at our ISO 13485 accredited facilities.

TYPICAL GRADES

PROCESSING

Mediprene 500M transparent series TPEs can be processed using standard thermoplastic processing methods, including injection moulding and extrusion.

Processing Temperatures

Extrusion： 140 to 180°C

Injection Moulding： 150 to 210°C

Mould： 20 to 40°C

Service Temperature Range： -50 to +100°C (unstressed material)

Adhesion to PP： Excellent

Presentation： Free flowing pellets that can be processed without predrying, when stored under normal conditions