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析出物和生物工艺产品

生物工艺必须将患者的潜在安全风险降至最低。其中包括确保有害浸出化合物不会从生产设备或储存材料进入产品。

生物工艺行业的实践使我们认识到一次性技术具有重要价值。因此，我们非常重视析出物和浸出物 (E&L) 的生产。我们的生物工艺产品经过精心设计，可最大程度降低影响药物安全性和有效性的浸出物风险。同时，我们高度重视对生物工艺产品的标准化 E&L 测试，旨在提高安全性并减少行业乱象。

我们采取的方式包括：

产品的全面析出物信息
符合 BioPhorum 发布的析出物方案
为客户提供 E&L 测试服务

全面的析出物信息

我们认为，生物工艺技术制造商应负责对其组件进行析出物测试。因此，我们会提供自己产品的析出物信息。
您可以按产品分类找到可用的析出物数据，如需帮助，请参阅下面的析出物数据指南。
登录监管支持申请，即可访问相关的析出物数据以供您用于风险评估。

访问析出物信息

符合 BioPhorum 析出物方案

我们根据 BioPhorum 析出物方案测试新产品，并有序更新旧的产品。

析出物数据指南和 BioPhorum 析出物状态

For information in identifying and accessing available extractable studies by product type, download the Extractables Data Guide Table further below. Portal access to the reports can be found via the links in the far right column of the table. Please note two separate portals are used for sharing depending on the specific report.

Product Type	Product description	Representative part number	Primary MOC ¹	Pretreatment²	Extractables study design			Applicable extractables reports	Report portal⁵
Product Type	Product description	Representative part number	Primary MOC ¹	Pretreatment²	USP<665>³	BioPhorum	Legacy⁴	Applicable extractables reports	Report portal⁵
Aseptic connector	ReadyMate™ DAC	28936688	PC	Gamma & Autoclave	H	X		Component family file: ReadyMate DAC. Extractables study: 17-002	Reg. Sup.
	Kleenpak® sterile connector	KPCHT02F11 KPCHT02M11	PC	Radiation and autoclave	H	X		USTR 3946 (Comprehensive summary)	ADC
	Kleenpak® Presto sterile connector	PSC1G8	PES	Radiation and autoclave	H	X		USTR 3947 (Comprehensive summary)	ADC
	Kleenpak® II sterile connector and disconnector	KPD01HB6	PSU	Radiation and autoclave	H	X		VAL-AS-004126-ER1(Autoclave) VAL-AS-004126-ER2(Radiation) VAL-AS-002951-ER3 (USP, Autoclave) VAL-AS-002951-ER4 (USP, Radiation)	ADC
Bioburden control filters	Kleenpak® capsules with Supor EAV membrane	KA3EAVP1G	PES, PP, Si	Radiation and autoclave	H	X		VAL-AS-006888-ER1 (Autoclave) VAL-AS-006888-ER2 (Radiation)	ADC
Bioburden control filters	Kleenpak® Nova capsules with Supor EAV membrane	NT6UEAVP1G	PES, PP	Radiation and autoclave	H	X		VAL-AS-006449-ER1 (Autoclave) VAL-AS-006449-ER2 (Radiation)	ADC
Biocontainers, mixers and bags	HyClone™ liquid media and buffer bags with CX5-14 film	N/A	Polyolefin	Gamma	M	X		Extractables study 15-004 CX5-14 film	Reg. Sup.
	HyClone™ liquid media and buffer bags with Cytiva Film Cell Culture 1	N/A	Polyolefin	Gamma	H	X		Extractables study 22-031 Cytiva™ Film Cell Culture 1	Reg. Sup.
	HyClone™ liquid media and buffer bags with Aegis 5-14 film	N/A	Polyolefin	Gamma	M	X		Extractables study: 15-005 Aegis5-14 film	Reg. Sup.
	ReadyToProcess™ bags with Fortem™ film	29381886	Polyolefin	Gamma	H	X		Assembly Family File: Assembly family ReadyToProcess bags with Fortem film - guide to extractables studies of components	Reg. Sup.
	ReadyCircuit™ bags with Fortem™ film China	29315051	Polyolefin	Gamma	H	X		Assembly Family File: Assembly family ReadyCircuit bags with Fortem film Extractables study: 15-003 Fortem film. Extractables study: 20-002 Fortem film in 2% Benzyl alcohol and Phosphate buffer pH 10	Reg. Sup.
	ReadyCircuit™ bags with ReadyKleer™ film	12410225	Polyolefin	Gamma	M	X	X	1) Extractables study: 15-002 ReadyKleer film 2) Validation guide: VG ReadyCircuit - extractables study on Hanging bag assembly.	Reg. Sup.
	WAVE Cellbag™ bioreactor and M*bag Mixing bags with Fortem™ film	CB0002L722-11-01PK	Polyolefin	Gamma	H	X		Extractables study: 15-003 Fortem film. Extractables study: 20-002 Fortem film in 2% Benzyl alcohol and Phosphate buffer pH 10. Validation guide: VG Cellbag Bioreactor bags with Fortem film	Reg. Sup.
	WAVE Cellbag™ bioreactor and mixer bags with Fortem™ film China	CB0001L722-01-08PK-CN	Polyolefin	Gamma	H	X		Extractables study: 15-003 Fortem film Extractables study: 20-002 Fortem film Validation guide: VG Cellbag Bioreactor bags with Fortem film China - presents data from Extractables study 15-003 plus studies on extractable antioxidant (TBPP) and its degradation products	Reg. Sup.
	WAVE Cellbag™ bioreactor and M*bag Mixing bag with Bioclear™ 11 film	CB0002L11-01	EVA	Gamma	M	X	X	1) Extractables study: 15-006 Bioclear 11 film 2) Validation guide: VG Cellbag bioreactor and Mbag mixing bag with Bioclear 11 film - presents study on Cellbag assembly/td>	Reg. Sup.
	WAVE Cellbag™ bioreactor and M*bag mixing bags with Bioclear™ 10 film	CB0002L10-01	EVA	Gamma			X	Validation guide: VG Cellbag bioreactor and M*bag mixing bag with Bioclear 10 film - presents studies on Cellbag assemblies	Reg. Sup.
	Xcellerex™ XDM bags with Fortem™ film	29300460	Polyolefin	Gamma	H	X		Assembly Family File: Assembly family XDM bags with Fortem film - guide to extractables studies of components	Reg. Sup.
	Xcellerex™ XDM bags with ASI 26/77 film	888-0086-N	Polyolefin	Gamma	M	X	X	1) Extractables study: 15-001 ASI 26/77 film 2) Validation guide: VG Xcellerex XDA disposable assemblies - extractables study on PEEK impeller and listing of surface areas of bag film and impellers	Reg. Sup.
	Xcellerex™ XDR bags with ASI 26/77 film	888-0070-C	Polyolefin	Gamma	M	X	X	1) Extractables study: 15-001 ASI 26/77 film 2) Validation guide: VG Xcellerex XDA disposable assemblies - extractables studies on PEEK impeller and polycarbonate material, with surface areas of bag film and impellers	Reg. Sup.
	Xcellerex™ XDR perfusion bags with ASI 26/77 film	29605397	Polyolefin	Gamma	M	X		Assembly Family File: Assembly family Bioreactor bags for Xcellerex APS - guide to extractables studies of components.	Reg. Sup.
	Xcellerex™ XDR- bags with ReadyKleer™ film	29398286	Polyolefin	Gamma	M	X		Asselby Family File: Assembly family XDR bags with ReadyKleer film 2) Validation guide: VG XDA disposable assemblies - extractables study on PEEK impeller and listing of surface areas of bag film and impellers	Reg. Sup.
	Xcellerex™ X-platform bioceactor bags	29696534	Polyolefin	Gamma	M	X		Assembly Family File: Assembly family Xcellerex X-platform bioreactor bags	Reg. Sup.
	Assembly family XDR-2000L Pro Max Bag	29724937	Polyolefin	Gamma	M	X		Assembly Family File: Assembly family XDR-2000L Pro Max Bag - guide to extractables studies of components.	Reg. Sup.
	Allegro™ 2D and 3D biocontainer chambers (film, port)	LGR0010L7700 (619-31A)	ULDPE, HDPE	Radiation	H	X		USTR 3941	ADC
	Magnetic mixer impeller	4100654	HDPE, PVDF, ceramic	Radiation	H	X		VAL-AS-006929-ER1	ADC
	Allegro single-use mixers	Various	Various	Radiation			X	USTR 2777a	ADC
	LevMixeer & Magnetic Mixers	LGRLMC0050L0001	ULDPE, HDPE	N/A				USTR 3983 (Materials, Surface Areas, and Applicable Extractables Reports)	ADC
Column housing	AxiChrom™ 50 to 200 columns	29016534	Glass	Cleaning in place (CIP)			X	Extractables study: 15-015 AxiChrom 50 to 200 columns	Reg. Sup.
	AxiChrom™ 300 to 1600 columns	29457805	Polymethyl methacrylate (PMMA)	CIP			X	Extractables study: 15-014 AxiChrom 300 to 1600 columns	Reg. Sup.
	BPG columns	18110301	Glass	CIP			X	Extractables study: 15-017 BPG columns	Reg. Sup.
	Chromaflow™ columns	18116141	PMMA	CIP			X	Extractables study: 15-016 Chromaflow columns	Reg. Sup.
	ReadyToProcess™ column housings ≤359 mm	N/A	Polyolefin	N/A	M	X		Validation guide: VG ReadyToProcess columns	Reg. Sup.
	ReadyToProcess™ column housings ≥450 mm	N/A	PMMA	N/A	M	X		Validation guide: VG ReadyToProcess columns	Reg. Sup.
Filling needles	Allegro™ single-use filling needle	DFNST1208632	PEEK	Radiation and autoclave	H	X		VAL-AS-008892-ER1 (Autoclave) VAL-AS-008892-ER2 (Radiation)	ADC
Filling needles	Allegro™ single-use filling needle	DFNLR1208632	PEEK, PP	Radiation and autoclave			X	USTR 2837a	ADC
Fittings	Polypropylene fittings	FY02311	PP	Radiation	M			VAL-AS-011234-ER	ADC
	Large-scale drain valve (O-ring)	SC00817 (O-ring)	SI	Radiation		X		VAL-AS-005734-ER	ADC
	Large-scale drain valve (spigot)	SC00816, SC00817	PBT	Radiation	M	X		VAL-AS-007006-ER1	ADC
Hardware system	ÄKTA™ Pilot 600	29274328	Fluorinated Ethylene Propylene (FEP)	CIP	M	X		Extractables study: 17-001 ÄKTA pilot 600	Reg. Sup.
	ÄKTA process™	N/A	Polyolefin	CIP	H	X	X	1) Extractables study: 15-019 ÄKTAprocess PP system 2) Extractables study: 22-001 ÄKTA process	Reg. Sup.
	UniFlux™ 30	29001375	Stainless steel	CIP			X	Extractables study: 15-020 UniFlux 30	Reg. Sup.
Process filters	Profile® II Filter cartridges	AB1Y0057PH4	PP, PE, Si	Radiation and autoclave	M			VAL-AS-009605-ER10 (Autoclave) VAL-AS-009605-ER11 (Radiation)	ADC
	Duo-Fine® II series filter	DFNT04510USM7	Fiberglass, PP, PE, Si	Autoclave	M			PHA-AM-014106-ER3	ADC
	ULTA™ Prime GF	28908433	Glass microfiber	Autoclave			X	Extractables study: 15-023 ULTA Prime GF	Reg. Sup.
	ULTA™ Prime PP	28908477	Polyolefin	Autoclave			X	Extractables study: 15-024 ULTA Prime PP	Reg. Sup.
	ReadyToProcess™ ULTA™ filter capsules	29410059	Polyethersulfone	Gamma			X	Validation guide: VG ReadyCircuit - extractables studies on ReadyToProcess ULTA HC; ULTA SG; ULTA CG; ULTA GF assemblies	Reg. Sup.
Sensors	Broadley James® single-use pH sensor	SU-800-1100-N	PEEK, EPDM, Si	Radiation	H			VAL-AS-010802-ER	ADC
Sensors	Broadley James® single-use bioprocessing container (BPC) gas wells	SU-100	PEEK, PPSU, Si	Radiation	M			VAL-AS-013144-ER	ADC
Sterilizing grade filters	Kleenpak® capsules with Supor® EKV membrane	KA3EKVP1G	PES, PP	Radiation and autoclave	H	X		USTR 3948 (Comprehensive summary)	ADC
	Kleenpak® Nova capsules with Supor® EKV membrane	NT6EKVP1G	PES, PP	Radiation and autoclave	M	X		VAL-AS-005068-ER1 (Autoclave) VAL-AS-005068-ER2 (Radiation)	ADC
	Kleenpak® Nova capsules with Supor® EX grade ECV membrane	NP6UECVP1G	PES, PP, Si	Radiation and autoclave	H	X		USTR 3949 (Comprehensive summary)	ADC
	Kleenpak® Nova capsules with Fluorodyne® EX grade EDF membrane	NT6UEDFP1G	PES, PVDF, PP, Si	Radiation and autoclave	H	X		USTR 3950 (Comprehensive summary)	ADC
	Kleenpak® Nova capsules with Fluorodyne® EX grade EDT membrane	NT6UEDTP1G	PES, PVDF, PP, Si	Radiation and autoclave	H	X		USTR 3951 (Comprehensive summary)	ADC
	Supor Prime Filter in Kleenpak® Spectrum Capsule and Cartridge Format	FC6ASFP1	PES, PP	Radiation and autoclave	H	X		VAL-AS-012571-ER1 (Autoclave) VAL-AS-012571-ER2 (Radiation)	ADC
	Kleenpak® Nova capsules with Fluorodyne II DFL membrane	NT6DFLP1G	PVDF, PP, Si	Radiation and autoclave	H	X		VAL-AS-005884-ER1 (Autoclave) VAL-AS-005884-ER2 (Radiation) VAL-AS-005884-ER2 (Radiation, 1% PS80)	ADC
	Kleenpak® capsules with Fluorodyne II DFL membrane	KA3DFLP1G	PVDF, PP	Radiation and autoclave	H	X		VAL-AS-002700-ER1 (01) (Autoclave) VAL-AS-002700-ER2 (01) (Radiation) VAL-AS-009149-ER1 (USP, Autoclave) VAL-AS-009149-ER2 (USP, Radiation)	ADC
	Polypropylene filter hardware used in Pall NP5L Kleenpak® Nova capsules and AB05 filter cartridges	FY00631, FY00630, FY00111	PP	Radiation and autoclave	H	X		VAL-AS-009305-ER1 (Autoclave) VAL-AS-009305-ER2 (Radiation)	ADC
	Kleenpak® Nova capsules with Posidyne® membrane	NT6NFZP1G	Nylon, PP, PE, Si	Autoclave	H	X		VAL-AS-008626-ER1	ADC
	Ultipor® N66 filter cartridges	AB1NF7P	PP, Nylon	Autoclave	M	X		PHA-AM-009775-1	ADC
	Emflon® II filter cartridges	AB1V0027PV	PVDF, PP	Autoclave	M		X	PHA-EU-000990-1 (Water) PHA-EU-000990-4 (50% Ethanol)	ADC
	Kleenpak® capsules with Emflon II membrane	KA3V002PV1G	PVDF, PP, EPDM	Gamma	M		X	PHA-EU-013161-ER	ADC
Tangitial flow filters (TFF)	Cadence® single-use TFF modules with Omega™ PES membrane	CSUM010T050, CSUM010T010	PES, PSU, PP	N/A			X	USTR 2906 (Water) USTR 2928 (25% Ethanol)	ADC
	T-Series TFF cassettes with Omega membrane	OS030T06	PES, urethane, PP	N/A			X	TR451402732	ADC
	Cadence inline diafiltration module with Omega PES membrane	DFOS030T120612	PES, PP, Si, PSU	N/A		X		PHA-AM-013313-ER1	ADC
	Cadence inline diafiltration module with Delta regenerated cellulose membrane	DFDC030T120612	Reg. cellulose, PP, Si	N/A		X		PHA-AM-013313-ER3	ADC
	ReadyToProcess Microfiltration hollow fiber filter	RTPCFP-2-E-6S	Polysulfone	Gamma			X	Validation guide: VG ReadyToProcess hollow fiber cartridges.	Reg. Sup.
	ReadyToProcess Ultrafiltration hollow fiber filter	RTPUFP-30-C-6S RTPUFP-750-E-6S	Polysulfone	Gamma			X	Validation guide: VG ReadyToProcess hollow fiber cartridges	Reg. Sup.
	Microfiltration hollow fiber filter	CFP-2-E-6A CFP-2-E-35STM	Polysulfone	CIP / Steam in place (SIP)			X	1) Extractables study: 15-021 Hollow fiber cartridges	Reg. Sup.
	Ultrafiltration hollow fiber filter	UFP-10-C-6A UFP-100-E-6A UFP-10-E-35 UFP-10-C-55STM UFP-10-E-55STM	Polysulfone	CIP / SIP	H	X	X	1) Extractables study: 15-021 Hollow fiber cartridges 2) Extractables study: 18-019 Hollow fiber ultrafiltration cartridges	Reg. Sup.
Filling flow kits	Single-Use Needle and Flow Path with DAC	610477, 600460	Silicone	Gamma	M	X	X	Assembly Family File: Assembly family information Single-Use Needle (SUN) and Flow Path with DAC	Reg. Sup.
	Allegro™ Connect Bulk Fill system	ACBFSCEPLC ACBFSCEIO ACBFSULIO ACBFSULPLC	Slicone, PP, PSE, PES	Radiation	H	X		VAL-AS-014453-ER	ADC
	ÄKTA ready™ Flow Kit	28930182	Silicone	Gamma	H	X		Validation guide: VG ÄKTA ready Flow Kit	Reg. Sup.
	ÄKTA ready™ XL Flow Kit	29264593	Silicone	Gamma	M	X		Validation guide: VG ÄKTA ready XL Flow Kit	Reg. Sup.
	ÄKTA readyflux™ Flow Kit	29187383	Thermoplastic elastomer (TPE)	Gamma	H	X		Validation guide: VG ÄKTA readyflux Flow Kit	Reg. Sup.
	ÄKTA readyflux™ XL Flow Kit	29403132 S	Silicone	Gamma	M	X		Assembly Family File: Assembly family ÄKTA readyflux XL flow kit - guide to extractables studies of components	Reg. Sup.
	ÄKTA ready™ 450 Flow Kit	29631244	Silicone	Gamma	M	X		Assembly Family File: Assembly family ÄKTA ready 450 flow kit - guide to extractables studies of components	Reg. Sup.
	Tubing kit for AxiChrom™ 200	28943020	Silicone	N/A			X	Extractables study: 15-027 Silicone Tubing Kit for AxiChrom 200	Reg. Sup.
	Tubing kit for chromatography hardware	28938126	Polytetrafluoroethylene (PTFE)	N/A			X	Extractables study: 15-028 Tubing PTFE	Reg. Sup.
	Xcellerex™ APS flow kit	29377111	TPE	Gamma	H	X		1) Assembly family file: Xcellerex APS flow kit - guide to extractables studies of components. 2) Extractables study: 19-002 Xcellerex APS flow kit.	Reg. Sup.
Virus filters	Kleenpak Nova capsules with Pegasus™ Prime virus removal filter membrane	NP6LUPRMP1S	PES, PP	Radiation and autoclave	H	X		VAL-AS-004360-ER (Radiation) VAL-AS-004360-ER1 (Autoclave)	ADC
	Kleenpak Nova capsules with Pegasus™ SV4 virus removal filter membrane	NT6USV4P1	PVDF, PE, PP, Si	Autoclave	H	X		VAL-AS-008472-ER1	ADC
	Kleenpak Nova capsules with Pegasus™ Protect virus prefilter membrane	NP6PRTP1	Nylon, PP, PE	Autoclave	H	X		VAL-AS-005331-ER1	ADC
	Kleenpak Nova capsules with Pegasus™ Protect virus prefilter membrane	NP6LPRTP1G	Nylon, PP, PE	Gamma	H	X		VAL-AS-005331-ER2	ADC
Note 1: Materials of construction: ULDPE = Ultra-low density polyethylene; HDPE = High-density polyethylene; EVA= Ethylenevinylacetate; PC = Polycarbonate; PSU = Polysulfone; PES = Polyethersulfone; PP = Polypropylene; PVDF = Polyvinylidene fluoride; PEEK = Polyether ether ketone; Si = Silicone elastomer; PBT = Polybutylene terephthalate; EPDM = Ethylene propylene diene monomer; PPSU = Polyphenylsulfone. Note 2: Radiation refers to X-ray and/or Gamma irradiation. Note 3: USP<665> is divided into High (H) or Moderate (M) risk level study design. Only fully satisfied USP <665> high risk dataset would be marked H, otherwise M. Note 4: Dataset available using different study design than USP<665> or BPOG. Note 5: See description on top how to access the portal. Note 6: Summary of extractable studies and other relevant information supporting risk assessment with all report files embedded

Updated: June 2024
How to access the data:
i. Navigate to cytiva.com/rsf
ii. Choose either Access Regulatory Support (Reg. Sup.) or the Accelerator Documentation Center (ADC) as noted in the Report portal column below.
iii. Log in to the portal. A confidentiality agreement will need to be accepted and approved before access to reports is provided.
Document USTR 3437 is now part of this data guide

Printable version of Extractables Data Guide Table