Evolution and Future Directions in Glass Packaging：A Comprehensive Revision of USP 660 -Desmond G. Hunt. Ph.D.pdf

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1、1 2021 USPContainersGlass:UpdateDesmond G.Hunt,Ph.D.Sr.Principal ScientistSuzhou,ChinaAugust,20242 2021 USPGlass Containers:Glass Container standard has a long history in the USPGlass Types I,II,and III was described in USP(1940)Type I(Borosilicate)Type II(Treated soda-lime)Type III(Soda-lime)The Co

2、ntainers Glass(2023)is very similar to the glass chapter published in USP(1965)Chapter is currently aligned with Pharm.Eur.Chapter 3.2.1.Glass Containers for Pharmaceutical UseRevision of was initiated in 2016 with the formation of the current Expert Panel The purpose of the Expert Panel is to revis

3、e to delineate the tests,testing procedures,technology requirements,and specifications for the different glass quality attributes3 2021 USP3 2021 USPUSP Glass Chapter:Expert PanelCurrent ChapterNomenclature:Type I Borosilicate;Type II Treated Soda-Lime-Silica;Type III Soda-Lime-SilicaGlass Grains Te

4、st(Identity Test to distinguish Type I from Types II and III)Inner Surface Hydrolytic Resistance Test(distinguishes Types I and II from Type III)Surface Etching Test(distinguishes high hydrolytic resistance is due to either the inner surface treatment or to the chemical composition of the glass cont

5、ainers)Extractable Arsenic Test(USP;Colorimetric Test)Spectral Transmission for Colored Glass ContainersPotential RevisionsNomenclature:Add treated aluminosilicate glass and quartz glassGlass Grains Test:Replace with a new test based on Wavelength Dispersive X-Ray Fluorescence(WDXRF)Inner Surface Hy

6、drolytic Resistance Test:Retain test but provide guidance on the application of the autoclave instructions in from a new studySurface Etching Test:Consider replacing test(uses Hydrogen fluoride)Extractable Arsenic Test:Develop a new test based on ICP Spectral Transmission for Colored Glass Container

7、s:Revise the test based on data from both borosilicate and soda-lime-silica colored glass 4 2021 USP4 2021 USPOption 1(Three-Tier)Nomenclature Options DiscussedOption 2(Five-Tier)5 2021 USPMarket Research mentioned that borosilicate,aluminosilicate and quartz are different materials and Option 1 doe

8、s not differentiate.Also,there was the perception that this option was less precise/ambiguous.Market Research mentioned that using sub-tiers for Type 1 would maintain focus on performance and add specificityOption 1B was discussed by the Expert Panel,and it was agreed to not divide Type I into sub-t

9、ier in order to avoid the creation of a perception of quality tiering(composition and identity)Nomenclature Options:DrawbacksType IClass ABorosilicateClass BAluminosilicateClass CQuartzOption 1BType I(Treated or Untreated)Type IIType IIIAluminosilicateBorosilicateQuartzTreated Soda-lime silica Soda-

10、lime silicaOption 1Market Research showed that Option 2 created the perception of quality tiering(Laddering).Type IType IIType IIIType IVType VBorosilicateTreated Soda-lime silica Soda-lime silicaAluminosilicateQuartz6 2021 USP6 2021 USPFDA Letter1.Request revision of USP Type 1 definition from comp

11、osition-based to performance based2.Global issues regarding glass production and concerned about resulting drug shortages3.Supportive of the use of new glass compositions that are not currently outlined in the USP,if they demonstrate equivalency or superior performance to Type 1 Borosilicate Glass,a

12、long with demonstrating suitability for the producta)Restrictive compendial definitions is impeding the adoption of new glass compositions with desirable characteristics.4.Several drug product monographs specify the use of specific glass composition which is delaying drug approvals5.FDA Requesta)Rev

13、ise b)Revise applicable monographsc)Revise as quickly as possible7 2021 USP7 2021 USPPossible Solution for Increasing Chapter Flexibility Revision1.Remove glass classification base on compositiona)Type I(Borosilicate Glass)b)Type II(Treated Soda-lime Silica)c)Type III(Soda-lime Silica)2.Define Type

14、I,II,and III containers by its performance 3.No change to test procedures or acceptance criteria8 2021 USPProposed:Revision9 2021 USPAccelerated Revision(Proposed IRA):TimelineRevision Draft Finalized:Jan 2023:Focused RevisionRevise to focus on“Type I Performance”vs.“Type I Glass Material”Publicatio

15、n Submission:Feb 2023PF Posting:March 2023Commenting Deadline:May 2023*Ballot Vote:June 2023IRA Posting Date:July 2023IRA Official Date:Sept.202310 2021 USP10 2021 USPChapter Current ChapterNomenclature:Type I Borosilicate;Type II Treated Soda-Lime-Silica;Type III Soda-Lime-SilicaGlass Grains Test(I

16、dentity Test to distinguish Type I from Types II and III)Inner Surface Hydrolytic Resistance Test(distinguishes Types I and II from Type III)Surface Etching Test(distinguishes high hydrolytic resistance is due to either the inner surface treatment or to the chemical composition of the glass containe

17、rs)Extractable Arsenic Test(USP;Colorimetric Test)Spectral Transmission for Colored Glass ContainersPotential RevisionsNomenclature:Add treated aluminosilicate glass and quartz glassGlass Grains Test:Replace with a new test based on Wavelength Dispersive X-Ray Fluorescence(WDXRF)Inner Surface Hydrol

18、ytic Resistance Test:Retain test but provide guidance on the application of the autoclave instructions in from a new studySurface Etching Test:Consider replacing test(uses Hydrogen fluoride)Extractable Arsenic Test:Develop a new test based on ICP Spectral Transmission for Colored Glass Containers:Re

19、vise the test based on data from both borosilicate and soda-lime-silica colored glass 11 2021 USP Nomenclature:Add treated aluminosilicate glass and quartz glass Glass Grains Test:Replace with a new test based on Wavelength Dispersive X-Ray Fluorescence(WDXRF)Inner Surface Hydrolytic Resistance Test

20、:Retain test but provide guidance on the application of the autoclave instructions in from a new study Surface Etching Test:Consider replacing test Extractable Arsenic Test:Develop a new test based on ICP Spectral Transmission for Colored Glass Containers:Revise the test based on data from both boro

21、silicate and soda-lime-silica colored glass USP Glass Chapter:Potential Revision12 2021 USP Glass Grains Test:Current test will not distinguish aluminosilicate,quartz,or borosilicate glass New test is needed to distinguish between the 4 glass“families”AluminosilicateBorosilicateQuartzSoda-lime-silic

22、a Elemental Composition by Wavelength Dispersive X-Ray Fluorescence(WDXRF)potential testUSP Glass Chapter:Potential Revision13 2021 USPWDXRF Study DesignWDXRF SpectrometerAn X-ray fluorescence spectrometer with a minimum 3kW power and 32 or 27 mm mask capable of measuring boronLaboratory OvenCapable

23、 of achieving 1000 C Quartz requires 1800 CProduces a round glass puck polished one side with a mirror finish Glass SamplesTubular Aluminosilicate,Borosilicate(33,51,70 expansion),Quartz,Soda-Lime-SilicaMolded Borosilicate(80 exp),Soda-Lime-SilicaClear Aluminosilicate,Borosilicate(33,51,70),Quartz,S

24、oda-Lime-SilicaAmber:Borosilicate(51,70 exp),Soda-Lime-Silica14 2021 USPChemical Composition Range of Glass FamiliesChemical CompositionWt%Quartz GlassAlumino-silicate GlassBorosilicate GlassCa.33 ExpansionBorosilicate GlassCa.51 ExpansionBorosilicate GlassCa.70 ExpansionSoda-Lime-Silica GlassSilico

25、n Dioxide(SiO2)9970-8078-8270-7665-7369-75Aluminum Oxide (Al2O3)6-122-3.54.5-74.5-70.5-4Boric Oxide(B2O3)110-138-125-80-1Sum Alkali Metal Oxides (Na2O and K2O)8-133-56-810-1212 16Sum Alkaline Earth Metal Oxides (CaO,MgO,BaO)3-7 0.21-34-9 10 15Wavelength Dispersive X-Ray Fluorescence(WDXRF)15 2021 US

26、P15 2021 USPIdentification by Chemical Composition The data obtained indicated that analysis of glass containers samples using WDXRF provides accurate compositional dataThis data provides a scientific basis for a Decision Tree that can identify the 4 glass families by chemical composition Aluminosil

27、icate,Borosilicate,Quartz,Soda-Lime-SilicaIn addition,it allows an approach to identify the sub-groups of Borosilicate glass based on the Coefficient of Expansion(ca.31,51,70)16 2021 USPSpectral Transmission for Colored Glass Containers Light transmission method was added to the USP in 1940,with the

28、 basis of the current method appearing in USP in 1955.The current spectral transmission requirement measures light transmission in the range of 290450 nm continuously or at intervals of 20 nmMethod is in alignment with the European Pharmacopoeia Requirements in differentiate between glass containers

29、 for parenteral and non-parenteral drug products.Acceptance criteria for parenteral drug products are shown in tableAcceptance criteria for non-parenteral drug products is a single maximum value of 10%at all wall thickness and any wavelength in the range of 290450 nm.USP Glass Chapter:Potential Revi

30、sionNominal Volume(mL)Maximum Percentage of Spectral Transmission at AnyWavelength between 290 and 450 nmFlame-Sealed ContainersContainers with ClosuresNMT 15025124520254015510351310203012NLT 202510Limits of Spectral Transmission for Colored Glass Containers for Parenteral Products 17 2021 USP The a

31、mount of light that passes through the glass wall depends on the glass composition Annealing time and temperature,and the wall thickness.Concerning the composition for colored glass containers;Type I borosilicate glass,typically iron and titanium are used to color the glass Type II and III soda-lime

32、-silica glass,typically iron and manganese are used to color the glass Current glass container market is not standardized,thus there is no reliable correlation between filling volume and the wall thickness.Current thesis:More scientifically sound to correlate spectral transmission to the wall thickn

33、ess of the glass containers rather than filling volume.USP Glass Chapter:Potential RevisionNominal Volume(mL)Maximum Percentage of Spectral Transmission at AnyWavelength between 290 and 450 nmFlame-Sealed ContainersContainers with ClosuresNMT 15025124520254015510351310203012NLT 202510Limits of Spect

34、ral Transmission for Colored Glass Containers for Parenteral Products 18 2021 USP A research protocol was designed to assess our current thesis and the validity of the current specifications for colored containers.The selected parameters were:Glass containers:Ampules,bottles,vials,cartridges,and syr

35、inges Manufacturing process:Tubular and molded Glass:Borosilicate and soda-lime-silica glass Tubular glass coefficient of thermal expansion(CTE)Borosilicate(ca.3.05.0 107/K 6.0 107/K)Low boron borosilicate(ca.8.0 107/K)Soda-lime-silica(ca.8.09.0 107/K)Molded glass CTE:Borosilicate(ca.6.0 107/K)Soda-

36、lime-silica(ca.8.09.0 107/K)Container WT:mm Data:Plot wall thickness versus light transmissionUSP Glass Chapter:Potential RevisionSpectral Transmission for Type I Tubular Colored Glass Containers19 2021 USPSpectral Transmission for Type I Tubular Colored Glass ContainersUSP Glass Chapter:Potential R

37、evision Wall thickness of tubular containers is relatively constantGlass manufacturers can supply data on wall thickness for their containers type;Or the thickness can be measured by the end userUSP collected data that covered three years of glass tubing and glass container production Data analyzed

38、for light transmission showed that a mathematical equation could be established between wall thickness and light transmittance%Tmax could be calculated for every WT,including a safety margin using the following equation:%Tmax=100*100.75*WT20 2021 USPSpectral Transmission for Type III Colored Glass C

39、ontainersUSP Glass Chapter:Potential RevisionThe obtained data indicated that Type II and III tubular glass containers does not fit the equation established for tubular Type I containers,Second equation for Type II and II containers would be required%Tmax could be calculated for every WT,including a

40、 safety margin using the following equation:%Tmax=100*100.40*WTMolded containers because they are produced by either blow-and-blow or press-and-blow processes wall thicknesses of the side wall and base canUsing wall thickness is not appropriate for molded containersThus,a single value minimum allowe

41、d transmittance value is proposed for all molded amber glass containers.21 2021 USPSpectral Transmission for Colored Glass Containers Use the following calculations for Maximum Allowed Spectral Transmission-WT=Wall Thickness(mm)Type I Containers:-%Tmax=100*100.75*WTType II and III Containers:-%Tmax=

42、100*100.4*WT Molded Containers(I,II,and III)have a maximum allowed transmission of 10%,regardless of the wall thicknessUSP Glass Chapter:Potential RevisionNominal Wall Thickness(mm)Maximum Allowed Specific Transmission(%Tmax)Borosilicate TubularContainersSoda-Lime-Silica TubularContainers0.5150660.5

43、10.642630.610.735580.710.830520.810.925480.911.021441.011.118401.111.215361.211.313331.311.411301.411.59281.511.67251.611.76231.711.85211.811.94191.91417Maximum Allowed Value for Specific Transmission for Colored Tubular Glass Containers22 2021 USPProposed changes to Containers Glass Nomenclature:Ad

44、d treated aluminosilicate glass and quartz glass Glass Grains Test:Replace with a new test based on Wavelength Dispersive X-Ray Fluorescence(WDXRF)Inner Surface Hydrolytic Resistance Test:Retain test but provide guidance on the application of the autoclave instructions in from a new study Surface Et

45、ching Test:Consider replacing test Extractable Arsenic Test:Develop a new test based on ICP Spectral Transmission for Colored Glass Containers:Revise the test based on data from both borosilicate and soda-lime-silica colored glass USP Glass Chapter:Potential Revision23 2021 USPGlass Chapters Revision Proposal Containers-Glass Evaluation of the Inner Surface Durability of Glass ContainersPublished:PF 50(5)September 2024Comment Deadline:November 31,2024