CertyForm

CertyForm is Velogy's healthcare-focused polymer family, bringing together polypropylene (PP) and high-density polyethylene (HDPE) for medical devices, pharmaceutical packaging, diagnostics and drug delivery. Genesis Polymers Europe supplies CertyForm materials and supports customers with grade selection and access to technical and regulatory documentation.

The family is positioned around consistent quality, regulatory reliability and dependable service for healthcare applications. Selection considers mechanical performance, optical properties, extractables and leachables requirements, sterilisation method and the documentation needed for the finished product.

Established materials retain their properties and specifications under their new CertyForm names. The relevant grade equivalence and regulatory documents support the transition in customer material records and qualification procedures.

Polypropylene (PP) for medical devices and pharmaceutical packaging

CertyForm PP includes homopolymers, random copolymers and impact copolymers. Homopolymers provide rigidity and heat resistance for device components, closures and labware. Random copolymers support transparent syringe barrels and other components requiring visual inspection. Impact copolymers balance stiffness with toughness for device housings and drug-delivery systems.

Applications include disposable syringes, auto-injectors, insulin pens, plungers, pharmaceutical packaging, laboratory equipment and diagnostic components. The exact grade should be selected against the device design, moulding process and intended sterilisation route.

Homopolymers for rigid medical components

CertyForm P1141 is a nucleated, antistatic homopolymer for healthcare caps and closures, pharmaceutical packaging and medical device components. Its MFR is 11 g/10 min at 230 °C/2.16 kg and its tensile modulus is 1800 MPa.

CertyForm P1001 provides an MFR of 7.5 g/10 min for closures, medical and laboratory components and selected film applications. CertyForm P1301 offers higher flow at 23 g/10 min for injection moulding, including syringes, closures and laboratory supplies. CertyForm P1701 extends the range to 75 g/10 min for high-flow moulding of three-piece syringes, closures and thin-wall components.

CertyForm P1680 is a radiation-stabilised homopolymer for applications requiring very high stiffness combined with good transparency, including selected syringe and laboratory components. Its MFR is 55 g/10 min. The sterilisation conditions and required retention of properties should be established for the final application.

CertyForm P0701 (3.4 g/10 min) broadens the selection with an extrusion and thermoforming homopolymer for pharmaceutical packaging and blisters.

Random copolymers for syringes and transparent components

CertyForm R1320 (25 g/10 min) is a random copolymer with slip additivation, designed for empty two-piece disposable syringes. It combines transparency for visual inspection with the sliding behaviour needed by the application. CertyForm R1321 is an additional two-piece syringe option with its own grade documentation.

CertyForm R1330 is a random copolymer for empty three-piece disposable syringes and transparent healthcare components. CertyForm R1380 is a radiation-stabilised random copolymer for syringe and medical moulding applications where the sterilisation route requires this formulation.

CertyForm R1540 combines high flow with nucleation and antistatic additivation for medical and healthcare mouldings. Its MFR is 48 g/10 min at 230 °C/2.16 kg, providing an option where thin-wall filling and transparency are both important.

Impact copolymer for tough medical components

CertyForm E1440 is a nucleated PP impact copolymer for medical components requiring a balance of stiffness and toughness. Applications include insulin pens, auto-injector and device housings, and in vitro diagnostic equipment. It has an MFR of 18 g/10 min at 230 °C/2.16 kg and a tensile modulus of 1750 MPa.

High-density polyethylene (HDPE) for healthcare packaging

CertyForm HDPE supports pharmaceutical closures, collapsible tube components and selected healthcare packaging applications. Choose the grade according to the conversion process, stiffness, flow and environmental stress crack resistance required.

CertyForm H0700 is designed for injection- and compression-moulded caps, closures and collapsible tube components. It combines good organoleptic performance with ESCR and supports ethylene oxide sterilisation applications. Its density is 0.954 g/cm³ and its MFR is 1.45 g/10 min at 190 °C/2.16 kg.

CertyForm H1201 provides higher flow for injection-moulded healthcare caps, closures and tube components, with an MFR of 8 g/10 min at 190 °C/2.16 kg. CertyForm H0201 is an extrusion blow-moulding option for jerry cans serving pharmaceutical and medical applications.

Sterilisation and regulatory documentation

Sterilisation compatibility is grade- and application-specific. Selected CertyForm PP grades support steam sterilisation or ethylene oxide processing. Radiation-stabilised grades such as CertyForm P1680 and R1380 provide options where irradiation is part of the sterilisation process. Confirm the permitted method, dose or temperature, ageing conditions and required property retention for the chosen material.

For HDPE closures, CertyForm H0700 supports ethylene oxide applications; it should not be assumed to be suitable for steam autoclaving. Final device and packaging validation must take account of geometry, processing and the complete sterilisation cycle.

Genesis Polymers Europe can help obtain the regulatory package relevant to the selected CertyForm grade. Discuss requirements for pharmacopoeial testing, applicable USP and European Pharmacopoeia statements, Drug Master File support, traceability and change notification at the start of the project. The applicable statements and scope must be established from the current documentation for that grade.

Choosing a CertyForm grade

For two-piece syringe barrels, start with CertyForm R1320 or R1321. For three-piece syringe applications, compare CertyForm R1330 and P1701 against transparency and flow requirements. For radiation-sterilised components, discuss CertyForm P1680 and R1380. For stiff, tough device housings, consider CertyForm E1440. For HDPE closures and tube components, compare H0700 and H1201; for extrusion blow-moulded healthcare jerry cans, examine H0201.

Frequently asked questions about CertyForm

What is CertyForm used for? CertyForm PP and HDPE serve medical devices, syringes, pharmaceutical packaging, diagnostic equipment, laboratory components and drug-delivery systems. Individual grades provide different combinations of rigidity, toughness, transparency and processing performance.

Does the CertyForm name mean that every grade is suitable for every medical application? No. Suitability depends on the individual grade, intended use, contact conditions, processing and sterilisation requirements. Review the applicable technical and regulatory documentation for the selected material.

Which CertyForm grades support radiation sterilisation? CertyForm P1680 and R1380 are radiation-stabilised options. Confirm the intended irradiation method, dose and property-retention requirements with Genesis Polymers Europe and the producer before qualification.

What is the difference between CertyForm P1001, P1301 and P1701? These PP homopolymers offer different flow levels: 7.5, 23 and 75 g/10 min respectively, measured at 230 °C/2.16 kg. Selection depends on part geometry, wall thickness, mould filling and the required mechanical performance.

Is there a CertyForm LDPE range on this page? This selection covers CertyForm PP and HDPE. For LDPE packaging film, explore KeyForm and AdvyForm and discuss the documentation required for the intended application.

Find your CertyForm grade

Contact Genesis Polymers Europe for CertyForm grade selection, samples, quotations and access to technical and regulatory documentation. Share the intended healthcare application, conversion process and sterilisation requirements so we can help identify the appropriate material. Explore KeyForm and AdvyForm for additional PP and PE applications.