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Rubber Components Selection for Optimal Drug Packaging Simon Rubber components selection for optimal drug packaging Simon Kervyn Manager Material Development March 11th, 2019 Agenda 1. Composition of pharmaceutical rubber 2. Extractables and leachables from rubber 3. Expectations of extractables information sharing 4. Different rubber compositions to steer properties 5. Compound for gamma sterilisation 2 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Stability and strength of a large industrial group Swiss origin, established in 1915 Revenues of approx. CHF 1,200 million Focused industrial player with two divisions: Sealing Solutions & Technical Components Listed on the SIX Swiss Exchange 3 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Multi-industry knowhow 4 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Datwyler Sealing Solutions – Health Care offer overview High quality components and closures for injectable drugs Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Datwyler Sealing Solutions – Health Care offer overview High quality components and closures for injectable drugs Vials Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Datwyler Sealing Solutions – Health Care offer overview High quality components and closures for injectable drugs Vials Syringes and cartridges Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com 1. Composition of Pharmaceutical Rubber 8 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Types of elastomeric closures – Compounded material of: 1. Elastomer 2. Filler 3. Cure system 4. Pigment 5. Other ingredients Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Composition – 1. Elastomers – Halobutyl (BromoButyl, ChloroButyl) – Natural rubber / Polyisoprene – Cleanest curing system – Natural rubber : latex allergy discussions – Lowest permeability – Historically the oldest elastomer type – High resistance to ageing – Need complex curing systems – Good elastic properties – Regular butyl still on the market, and also – Polyisoprene (synthetic) replaces Natural newer types like BIMS (Brominated rubber isobutylene para-methylstyrene) – Nitrile rubber – Typically used for mineral oil based drugs – Silicone rubber – High permeability – Typically not used for parenteral applications – SBR (styrene-butadiene rubber) – Intermediate permeability – EPDM rubber – Typically used for pre-assembled EtO – For niche applications sterilized components (e.g. Needle Shields) Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Composition – 2. Fillers • Fillers give mechanical strength (stiffness) to a rubber • Attributes physical properties to a rubber compound • More filler = Harder compound Better for gliding profile plungers Better against stickiness in bulk Worse for stopper piercing (coring!) • Inorganic fillers (‘white compounds’) – Aluminum silicate (clay) – Magnesium silicate (talc) – [Calcium carbonate] (calc) • Carbon black (‘black compounds’) – Undesired for cleanliness reasons – May be associated with PNA’s Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Composition – 3. Curing agents • Cure system: – Crosslinking agent – Activator : gives the onset of vulcanization – Accelerator : speeds up the vulcanization • Easily extractable organic molecules such as thiurams, sulfonamides, thiazoles, ... • Modern cure systems – Aim at giving little extractables Sx • Historic cure systems – Use easily extractable organic accelerators Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Composition – 4. Color pigments • Inorganic pigments – Grey colors: – Titanium dioxide White – Traces of carbon black Black – Red colors: – Oxides of iron Red • Organic pigments – Avoided in modern compounds Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Composition – 5. Other ingredients • Halobutyl polymer stabilizers – Calcium stearate – Epoxydized soybean oil (ESBO) • Anti-oxidants – Already present in halobutyl elastomer – Hindered phenol type anti-oxydants – Additionally added to improve environmental stability (ageing) • Plasticizer, Waxes, Oils – High polymeric weight plasticizers, Paraffinic oil – To tune a formulation (e.g. reduce coring) • Processing aids Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com 2. Extractables and leachables from rubber 15 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com E&L of elastomeric closures – Extractables profiles – Too many ingredients should Monomer (Isobutylene) be avoided : negative impact Rubber Oligomers (C13, C14) on E-profile Calcium Stearate Fatty acids (Stearic, Palmitic) “what you don’t put in, Elastomer can’t come out” Anti-Oxidant (BHT, Irganox 1010) Br-/Cl- ions Residual solvent Filler Metallic ions (Mg, Al, Si, Ca) Sulphur, Sulphur derivates Phenol formaldehyde resin Cure System Rubber Metallic ions (Zn, Mg) Peroxyde Pigment Metallic ions (Ti, Fe) Low molecular fragments (Plasticizers) Additives Paraffinic oil, Waxes Anti-oxidants Impurities (Phenol derivates,Alkanes) Unknowns Unknown additives (AO, inhibitors) And many more… Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Significant improvements in recipes and raw material selection Curing Color Fillers Additives systems Pigments Sterically High Inorganic Silicates hindered molecular (TiO2, C, (Talc, Clay) curing weight, Fe3O4) agents purified No Carbon No doubtful No organic No simple Black, accelerators colorants waxes, oils No Calc 17 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com E profile : OLD vs MODERN Difference in Extractable Results for an OLD vs MODERN rubber (IPA Extract; GC/MS analysis) Internal Standard “OLD” RUBBER “MODERN” RUBBER Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com E profile : MODERN vs MODERN COATED Difference in Extractable Results for a Coated vs Uncoated rubber, for the same rubber grade (IPA Extract; GC/MS analysis) Internal Standard COATED “MODERN” RUBBER UNCOATED “MODERN” RUBBER Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Extractable profile over time – Extractables study is performed on the same batch at manufacturing date (0 year), after 1 year, 2 years and [ongoing:7 years] • Negative trend in volatiles (Anti-Oxidant, Oligomers) • No trend in non-volatiles (Fatty acid) 20 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com 3. Expectations of Extractables information sharing 21 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Information transfer Sharing Pharmacopeial data E-documentation from supplier NDA L-study set up : Drug details drug company & E-doc. from supplier NDA – Note : Rubber compositions are extremely sensitive information to closure manufacturers – Rubber compound recipes are in general not patented – ‘Trust <-> control’ 22 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Extractables documentation throughout the years Pharmacopeial Potential Potential Controlled testing Extractables list Extractables study Extractables study Theoretical list + actual study + semi-quantitative + screening + extra extract. media + gamma (if applicable) 23 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Nelson Labs – Datwyler Partnership … more than a decade bringing analytical and rubber compounding experts together enabling the best services • A premium service to the pharmaceutical packaging industry enabling a fast and safe regulatory approval. • Common R&D programs show the ambition to continue offering the best-in-class knowledge and expertise in pharmaceutical elastomer formulations. • Enjoy a discount for all your analytical study work. 24 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com 4. Different rubber formulations to steer properties 25 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Smart selection of ingredients can tune a rubber compound E.g. recipe based on E.g. blend of hydrophobic E.g. MgO replaces halobutyl and SBR ingredients will show ZnO to avoid Zn-ion can tune the better E-profile with extraction permeability aqueous drugs. E.g. low water E.g. Omniflex coated E.g. soft compound absorption rubber for for multi piercings compounds for lyo sensitive/large with needle applications molecule drugs 26 Rubber components selection for optimal drug packaging, March 11th, 2019 / © Datwyler, www.datwyler.com Smart selection of ingredients can tune a rubber compound E.g. recipe based on E.g. blend of hydrophobic E.g. MgO replaces halobutyl and SBR ingredients will show ZnO to avoid Zn-ion can tune the better E-profile with extraction
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