Drug Delivery Systems Auto-injectors and Drug Delivery Pens

REGULATORY SUPPORT • Drug delivery devices • Pharmaceutical packaging • Medical equipment KEY CHARACTERISTICS • Manufactured at four ISO 13485 certified sites, providing global consistency and increased security of supply • Documented change control beyond CAS number level, reducing the risk of change • Allows crystallization in semi-crystalline polymers to begin faster and complete earlier REGULATORY SUPPORT • Raw materials tested to: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* APPLICATION BULLETIN * FDA/EU compliance information available upon request Healthcare use limitations apply—see below.

Avient’s portfolio of healthcare additives helps enhance the performance and functionality of plastics used in drug delivery devices, in vitro diagnostic devices, and pharmaceutical packaging.

Drug Delivery Systems Auto-injectors and Drug Delivery Pens

KEY CHARACTERISTICS • Globally harmonized formulations are manufactured at four ISO 13485 certified medical sites, providing global consistency and increased security of supply • Documented change control available • A range of standard colors eliminates color matching to expedite development time • The portfolio includes compliant colors for use in: - Needle hub applications: ISO 6009 - Ophthalmic container closures (American Academy of Ophthalmology) REGULATORY SUPPORT • A library of pre-tested raw materials including: - ISO 10993-1 and USP biological evaluation - European Pharmacopeia 3.1.3/3.1.5 (polyolefin) - USP (polyethylene) - ICH Q3D elemental impurities • Registered Drug Master File (Type III) and/or Device Master File • Food contact established with FDA/EU* HEALTHCARE APPLICATIONS • Medical devices such as catheters, surgical and dental instruments, and drug delivery devices • Pharmaceutical packaging including vials and bottles • Diagnostics for blood analysis or In Vitro Diagnostics (IVD) PRODUCT BULLETIN & COLOR CARD * FDA/EU compliance information available upon request; exceptions may occur Color Pantone Reference PE Base PP Base Transparent PP Base PEBA Base PC Base Transparent PC Base* ABS Base* White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206 Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958 Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939 Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037 Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039 Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978 Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402 Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404 Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406 Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070 Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068 Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072 Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297 Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295 Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871 Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869 Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896 Colors may vary from actual color shown.

SOLVING PRODUCTION BOTTLENECKS WITH A CUSTOMIZED ADDITIVE FORMULATION © 2020, All Rights Reserved Avient Corporation, 33587 Walker Road, Avon Lake, Ohio USA 44012 To learn more about WithStand Antimicrobials, contact Avient at +1.844.4AVIENT (1.844.428.4368) THE CHALLENGE A well-known manufacturer of private label toothbrushes and dental care products for national drug store chains was experiencing several production problems in its molding operations. Second, lead times for the additive were long and deliveries slow, which gave rise to production bottlenecks.

FDA-designed raw materials shall be produced according to the requirements specified by the Food, Drug, and Cosmetic Act. Deliveries will be on time and in full, as defined in the PO, unless otherwise agreed upon. Avient categorization for a “supplier” FDA Food & Drug Administration IATF International Automotive Task Force Interested Party Term referenced in ISO 9001.

Food and Drug Administration (FDA) regulations. The company also sought a vendor who could provide rapid delivery and reliable material supply to avoid production delays.

You may recognize the two healthcare megatrends that are driving global demand for pharmaceutical packaging, medical devices and drug delivery devices: economic gains in developing nations and an aging global population that requires treatment for chronic conditions. Because they remove the need to wash products and simplify bonding to rigid substrates, TPEs require only one to two minutes of processing time from start to finish, and are ideal when producing dynamic and static seals, liquid storage and delivery packaging, and infusion therapy devices.

When tender of delivery of the property to the party entitled to receive it has been made, but delivery has been refused, or if carrier is unable to make delivery, carrier's liability as a warehouseman will begin when carrier has placed said property in a warehouse or storage facility under reasonable security. Claims of loss, damage or delay must be mailed within nine months of delivery, or in the case of failure to make delivery, within nine months after a reasonable time for delivery has elapsed. All claims for recovery by SHIPPER as provided herein and as to each shipment, must be filed with CARRIER within nine (9) months of the date of delivery or tender for delivery of that shipment or if not tendered or delivered must be filed with nine (9) months of the date when delivery or tender of delivery of that shipment reasonably should have been made.