Page 32 - Plastics News January 2020

FeAtures

Clariants MEVOPUR® and Remafin®-EP For Healthcare Applications

lariant, a world leader in specialty chemicals had minute problems with <661.1> testing as the 2020 deadline
Ccompletion of testing on ingredients in its MEVOPUR approaches, Compliance to <661.1> represents a major
and REMAFIN-EP product ranges in order to bring them change, involving not only a significant modernization
into full compliance with USP <661.1>. The new standard of test methods, but also a more robust risk assessment
for pharmaceutical packaging and drug delivery devices process: "The major consequence of this change is that
doesn't take effect until May 2020, in 2020, the 'food contact statements' that have long
when it will impact all current and supported the use of many materials in drug packaging
future drugs on the U.S. market. will be deemed 'insufficient' to support their future use.
Making the pressentationat the PVI Thereafter, packaging materials for any category of drugs,
2020, Umang Shah National Sales from solid oral dose to higher risk ophthalmic solutions,
& Marketing Manager Haelthcare must be supported by data from in-vitro tests specified
Polymer Solutuions ,Clariant in USP<661.1> (e.g. for extractable metals) and USP for
Chemicals India Masterbatches, cytotoxicity." Though all manufacturers must prove the
elaborated on the performance and compliance of their finished pharmaceutical packages and
attributes of compunds. Clariant is drug delivery devices to the new standard, Duckworth
completing the testing process says that customers who select MEVOPUR and REMAFIN-
now to help customers "future-proof" packaging launched EP products for use in those packages or drug delivery
in the interim and, in addition, to offer data to support
the ICH-Q3D guidelines for risk assessment of elemental
7 Confidential, Polymer Modification with Color and Function - Innovative Products for Medical, IVD and Pharma Pack devices can develop and test their products with an added
Umang Shah, Masterbatch, India, Healthcare Polymer Solutions, 17.01.2020
measure of confidence and avoid the costs of testing and
Healthcare Polymer Solutions - supporting regulatory and change control submission twice: "If our
processes … 1 of 2 own tests have already
indicated that there is a
Product range ISO USP<87>, USP ICH-Q3D EP DMF low risk of an ingredient
10993* <88> <661.1> E.I. 3.1 type III in t h e pa cka ging
MEVOPUR-LQ Liquid colorants for silicones and transparent PET   * 
/PP *(3) *(3) interacting with the drug,
PLASTIWARD End to end security system with partner and      
global expert SICPA. then the customer can
REMAFIN-EP White LLDPE 60, 70%; HDPE; PP tested to new       proceed with additional
USP<661.1>
AAO Ophthalmic closure 13 standard AAO colors in PE. tested to USP       tests, such as required
colors standard leachable and shelf life
Standard USP/ISO color Standard opaque and transparent colors PP, PE,      
range COC, PC, PEBA, …..PEEK, FEP stability testing, with a
Clarifying PP Sorbitol-free – new possibilities in packaging      
ocular solutions greater confidence that
Friction reduction / process Non-migrating additive range MB for PE, PP,     the package concept is
aid ABS, POM *(3) *(3)
Protection during gamma / e- Gamma destroys the properties of PP and COP.    1 .   1 . ( 2 ) going to get through these
beam sterilization Reduction in yellowing using CC Technology
tougher regulations."
Bormed PP, PE Polyolefin resins with Healthcare service solution   *(3 -   In longer term the
production controls in
impurities in drugs. "The ICH-Q3D guideline strengthens Clariant's ISO:13485 medical manufacturing plants help
the risk assessment process by evaluating not only the to ensure that MEVOPUR and REMAFIN-EP materials and
pharmaceuticals themselves, but also the packaging to ingredients remain free of change and thus supporting
ensure it is not the source of elemental impurities in continuous compliance worldwide. Whether you need color
drugs. During the transitional period, the FDA allows masterbatch concentrates for dilution into other polymers,
the industry to make new filings under the older or the or small and large lot pre-color compounds, we can provide
new <661.1> standard, but in 2020, all existing and new products that suit your preferred manufacturing processes.
drug / package combinations will need to be tested and Otherwise, if you require more functional additives such
compliant to the new standard. By completing its testing as nucleants, clarifiers, lubricants or antmicrobials, we
early, Clariant is helping customers get out in front of can offer these in combination with our “combi” solution."
these regulatory changes and avoid the potential for last-

Plastics News Januar y 2020 32