Sartorius Stedim Biotech GmbH

85030-538-37 Minisart®-RC|SRP|NY
Certificate for August-Spindler-Strasse 11
®
Minisart-RC|SRP|NY 37079 Goettingen, Germany
www.sartorius-stedim.com Gebrauchsanweisung und Produktdaten
The purpose of this Certificate is to provide information about Sartorius Stedim Biotech Füllen Sie die zu filtrierende Flüssigkeit Vorsicht bei Spritzen mit einem Volumen
Specifications subject to change without notice.
products’ compliance with quality standards. Sartorius Stedim Biotech certifies that its Printed and copyrighted by Sartorius Stedim Biotech GmbH in eine Spritze mit Luer Anschluss. Setzen kleiner als 10 ml. Hierbei wird die maximale
products listed below meet the high quality requirements placed on them. W106.07 Publication No.: SL-6154-p09061 Sie den Minisart® RC|SRP|NY auf den Luer- Druckbelastbarkeit von 6 bar schnell
Ver. 06 | 2009 Anschluss der Spritze. Filtrieren Sie den überschritten.
Product Catalog No. Inhalt der Spritze in ein Gefäß bzw. eine Minisart® RC|SRP|NY jeweils nur für eine
Apperatur. Probe benutzen, um eine Verschleppung
Minisart® RC: von Proberesten sicher zu vermeiden.
17821; 17822; 17761; 17762; 17764; 17765 Achtung! Wenn die maximale Rückgewin-
nung der zu filtrierenden Probe erreicht Application:
Minisart® SRP: werden soll ziehen Sie nach der Filtration Minisart® RC zur Hochreinigung von
17820; 17558; 17559; 17573; 17574; 17575; 17576 noch einmal Luft in die Spritze und wässrigen|organischen Lösungsmitteln
drücken Sie die Restflüssigkeit durch den Minisart® SRP zur Hochreinigung von
Minisart® NY: Minisart® (=Bubble Point überwunden). aggressiven Flüssigkeiten.
Das Totvolumen reduziert sich.
17845; 17846, 1776 B, 1776 C
I. Good Manufacturing Practice Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
These products have been manufactured in a Sartorius Stedim Biotech facility in Totvolumen 5 μl 10 μl 100 μl 10 μl
compliance with the FDA regulations and Good Manufacturing Practice standards. Anschlüsse LL/L LL/L LL/L LL/L
Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
II. 100% Tested during Manufacture Membran Cellulose Cellulose Cellulose Nylon
Each unit is tested for membrane and housing integrity during manufacture. Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
III. Quality Assurance Lot Release Criteria Totvolumen 5 μl 10 μl 100 μl 100 μl
Anschlüsse LL/L LL/L bzw. LL/Spike LL/L LL/L
Each manufacturing lot has been tested and released according to the following Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
in-house criteria: Bubble point, housing integrity, flow rate for water or ethanol Membran PP verstärktes PTFE PP verstärktes PTFE PP verstärktes PTFE Nylon
IV. HPLC Certification CE
Minisart® SRP 0120 17575-ACK, einzeln steril verpackt.
The membranes used with methanol/water and acetonitrile/water did not show Anwendung zur Sterilbelüftung oder Sterilfiltration von Gasen, auch für medizinische
any artifacts or interference peaks in the range of 200 – 300 nm during HPLC. Zwecke.
Minisart® NY 17845-ACK; 17846-ACK, einzeln steril verpackt.
V. Sartorius Stedim Biotech has been certified for compliance with ISO 9001.

Dr. Ralf Wawotzny

Director of Quality Filtration Products
Directions for Use and Product Data Instrucciones de uso y datos de productos HPLC Certification
Fill a syringe, which has a luer connector, Take care when using syringes with a Llene con el líquido a filtrar una jeringa muerto se reduce. Tenga cuidado con las The membranes used with methanol|water and acetonitrile |water did not show any
with the liquid to be filtered. Attach the volume less than 10 ml, since they can easily con nonexión Luer. Coloque el filtro jeringas cuyo volumen es menor que 10 ml; artifacts or interference peaks in the range of 200–300 mm during HPLC.
Minisart® RC|SRP|NY to the luer connector generate a pressure greater than the burst Minisart® RC|SRP|NY en la conexión Luer aquí se supera rápidamente la resistencia
on the syringe. Filter the contents of the pressure rating for Minisart® housings. de la jeringa. Filtre el contenido de la a la presión de 6 bar.
syringe into a flask or apparatus. Use Minisart® RC|SRP|NY for a single jeringa en un recipiente o dispositivo. Utilice Minisart® RC|SRP|NY sólo para una Methanol Filtrat Methanol
sample only to avoid carrying over residues muestra, para evitar en forma segura el
Important Note! If you need to ensure of one sample to the next one. Advertencia: Si ha de alcanzarse la máxi- arrastre de residuos de la muestra anterior. Sample Name: Methanol Channel: UV_VIS_2 Sample Name: Filtrat Methanol Channel: UV_VIS_2
maximum recovery of the sample, draw air ma recuperación de la muestra a filtrar, Aplicaciones: Vial Number: RA3 Wavelength: 214 Vial Number: RA4 Wavelength: 214
Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
into the syringe after filtration and press Applications: succione aire en la jeringa una vez más, Minisart® RC para la ultrapurificación de
Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
in the plunger to filter the residual liquid Minisart® RC for ultracleaning of después de la filtración, y luego presione el disolventes acuosos|orgánicos. Recording Time: 4.7.01 17:02 Sample Weight: 1,000
Recording Time: 4.7.01 15:05 Sample Weight: 1,000
through the Minisart® (= overcomes the aqueous|organic solvents resto de líquido a través de Minisart® Minisart® SRP para la ultrapurificación de Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
bubble point). This procedure reduces the Minisart® SRP for ultracleaning of (= punto de burbuja superado). El volumen líquidos agresivos Injection Volume: 100,0 Injection Volume: 100,0
hold-up volume. aggressive liquids
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volumen muerto 5 μl 10 μl 100 μl 10 μl
Hold-up volume 5 μl 10 μl 100 μl 10 μl Conexiones LL/L LL/L LL/L LL/L
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Caja portafiltro Polipropileno Polipropileno Polipropileno Polipropileno
luer slip outlet luer slip outlet luer slip outlet luer slip outlet Membrana Celulosa Celulosa Celulosa Nylon
Housing Polypropylene Polypropylene Polypropylene Polypropylene
Membrane Cellulose Cellulose Cellulose Nylon Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
Volumen muerto 5 μl 10 μl 100 μl 100 μl
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Conexiones LL/L LL/L, o bien, LL/Spike LL/L LL/L
Hold-up volume 5 μl 10 μl 100 μl 100 μl Caja portafiltro Polipropileno Polipropileno Polipropileno Caja portafiltro
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Membrana PP reforzado PTFE PP reforzado PTFE PP reforzado PTFE Nylon Acetonitril Filtrat Acetonitril
luer slip outlet luer slip outlet luer slip outlet luer slip outlet
Housing Polypropylene (PP) Polypropylene (PP) Polypropylene (PP) Polypropylene CE
Minisart® SRP 0120 17575-ACK, en embalaje individual estéril. Sample Name: Acetonitril Channel: UV_VIS_4 Sample Name: Filtrat Acetonitril Channel: UV_VIS_4
Membrane PP-reinforced PTFE PP-reinforced PTFE PP-reinforced PTFE Nylon Vial Number: RA1 Wavelength: 280 Vial Number: RA2 Wavelength: 280
Aplicación para el venteo estéril, o bien para la filtración estéril de gases. Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
CE
Minisart® NY 17845-ACK; 17846-ACK, en embalaje individual estéril. Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
Minisart® SRP 0120 17575-ACK, individually steriled-packaged.
Recording Time: 5.7.01 14:13 Sample Weight: 1,000 Recording Time: 5.7.01 18:08 Sample Weight: 1,000
Designed for sterile venting or sterile filtration of gases. Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
®
Minisart NY 17845-ACK; 17846-ACK, individually steriled-packaged. Injection Volume: 100,0 Injection Volume: 100,0

Istruzioni per l’uso e dati del prodotto

Mode d’emploi et caractéristiques du produit
Versare il liquido da filtrare in una siringa attenzione con le siringhe con volume
provvista di attacco Luer. Montare minore di 10 ml, poiché la massima pressio-
Remplissez une seringue munie d’un inférieur à 10 ml. Avec ces seringues, on peut
sull’attacco Luer della siringa il dispositivo ne di rottura dell'housing di 6 bar può
embout Luer avec le liquide à filtrer. Placez rapidement dépasser la capacité de pression
di filtrazione Minisart® RC|SRP|NY. Filtrare essere facilmente superata. I dispositivi
le Minisart® RC|SRP|NY sur le raccord Luer maximale de 6 bars.
il contenuto della siringa in un recipiente Minisart® RC|SRP|NY devono essere usati
de la seringue. Filtrez le liquide contenu dans Veillez à n’utiliser chaque Minisart®
o in una apparecchiatura apposita. ogni volta solo per un campione per evitare
la seringue dans un flacon ou un appareil. RC|SRP|NY qu’une seule fois afin que le
il contaminazioni crociate.
liquide à filtrer ne soit pas en contact avec
Attenzione! Se si deve raggiungere il
Important ! Si vous souhaitez récupérer des restes d’échantillon.
recupero massimo del campione da Applicazione: Symbole In-Vitro-Diagnostika Sterilisation mit Dampf
le maximum de l’échantillon filtré, aspirez In-Vitro-Diagnostics sterilized, hot steam
filtrare, aspirare ancora una volta aria Minisart® RC per la purificazione di
une nouvelle fois de l’air dans la seringue Application: Nicht zur Wiederverwendung Dispositif médical de diagnostic Méthode de stérilisation utilisant
nella siringa dopo la filtrazione e spingere solventi acquosi|organici. Minisart® SRP
après la filtration et refoulez le liquide Minisart® RC est destiné à l’ultrapurifica- Single Use in vitro la vapeur ou la chaleur séche
il liquido rimanente attraverso Minisart® per la purificazione di liquidi aggressivi. Ne pas réutiliser Para uso en diagnóstico in vitro Esterilización por vapor caliente
restant à travers le Minisart® (= dépasse- tion de solvants aqueux |organiques.
(= superato il punto di bolla). In questo Minisart® NY per la filtrazione di soluzioni No reutilizable Per uso diagnostico in vitro Sterilizzazione con vapore caldo
ment du point de bulle). Cela réduit le Minisart® SRP est destiné à l’ultrapurifica- Monouso
modo il volume morto diminuisce. Fare alcaline.
volume mort. Faites attention lorsque vous tion de liquides corrosifs. verwendbar bis pyrogenfrei
travaillez avec des seringues d’un volume Bestellnummer Use before non-pyrogenic
Order Number Utiliser jusqu'au non pyrogène
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Référence du catalogue Fecha caducidad Apirógeno
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volume morto 5 μl 10 μl 100 μl 10 μl Número de referencia Data di scadenza Apirogeno
Volume mort 5 μl 10 μl 100 μl 10 μl Attacchi LL/L LL/L LL/L LL/L Codice d'ordine
Housing polipropilene polipropilene polipropilene polipropilene Chargenbezeichnung Porengröße
Raccords LL/L LL/L LL/L LL/L Lot Number Pore size
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante cellulosa cellulosa cellulosa Nylon Achtung! Code du lot Taille de pore
Membrane filtrante Cellulose Cellulose Cellulose Nylon Warning! Número de lote Tamaño de poro
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Attention! Numero di lotto Porosità
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Volume morto 5 μl 10 μl 100 μl 100 μl
Atención!
Volume mort 5 μl 10 μl 100 μl 100 μl Attenzione! Sterilisation mit Ethylenoxid Temperaturbegrenzung
Attacchi LL/L LL/L o LL/Spike LL/L LL/L sterilized, ETO maximum and minimum
Raccords LL/L LL/L ou LL/minipointe LL/L LL/L Housing polipropilene polipropilene polipropilene polipropilene Méthode de stérilisation util- temperature
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante PTFE rinforzato PTFE rinforzato PTFE rinforzato Nylon Hersteller isant de l'oxyde d'éthyléne Limite de température
Membrane filtrante PFTE renforcé PFTE renforcé PFTE renforcé Nylon con PP con PP con PP Manufacturer Esterilización por ETO Temperatura máxima y mínima
polypropyléne polypropyléne polypropyléne Fabricant Sterilizzazione con ETO Temperatura massima e minima
CE Fabricante
CE
Minisart® SRP 0120 17575-ACK, in confezione singola sterile. Produttore Sterilisation durch Bestrahlung
Minisart® SRP 0120 17575-ACK, en emballage individuel stérile. Utilizzo per l’aerazione sterile o la filtrazione sterile di gas. sterilized, irradiated
Utilisation pour la ventilation stérile ou la filtration stérile de gaz. ®
Minisart NY 17845-ACK; 17846-ACK, in confezione singola sterile. Méthode de stérilisation util-
®
Minisart NY 17845-ACK; 17846-ACK, en emballage individuel stérile. isant l'irradiation
Esterilización por radiación
Sterilizzazione per irradiazione
Directions for Use and Product Data Instrucciones de uso y datos de productos HPLC Certification
Fill a syringe, which has a luer connector, Take care when using syringes with a Llene con el líquido a filtrar una jeringa muerto se reduce. Tenga cuidado con las The membranes used with methanol|water and acetonitrile |water did not show any
with the liquid to be filtered. Attach the volume less than 10 ml, since they can easily con nonexión Luer. Coloque el filtro jeringas cuyo volumen es menor que 10 ml; artifacts or interference peaks in the range of 200–300 mm during HPLC.
Minisart® RC|SRP|NY to the luer connector generate a pressure greater than the burst Minisart® RC|SRP|NY en la conexión Luer aquí se supera rápidamente la resistencia
on the syringe. Filter the contents of the pressure rating for Minisart® housings. de la jeringa. Filtre el contenido de la a la presión de 6 bar.
syringe into a flask or apparatus. Use Minisart® RC|SRP|NY for a single jeringa en un recipiente o dispositivo. Utilice Minisart® RC|SRP|NY sólo para una Methanol Filtrat Methanol
sample only to avoid carrying over residues muestra, para evitar en forma segura el
Important Note! If you need to ensure of one sample to the next one. Advertencia: Si ha de alcanzarse la máxi- arrastre de residuos de la muestra anterior. Sample Name: Methanol Channel: UV_VIS_2 Sample Name: Filtrat Methanol Channel: UV_VIS_2
maximum recovery of the sample, draw air ma recuperación de la muestra a filtrar, Aplicaciones: Vial Number: RA3 Wavelength: 214 Vial Number: RA4 Wavelength: 214
Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
into the syringe after filtration and press Applications: succione aire en la jeringa una vez más, Minisart® RC para la ultrapurificación de
Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
in the plunger to filter the residual liquid Minisart® RC for ultracleaning of después de la filtración, y luego presione el disolventes acuosos|orgánicos. Recording Time: 4.7.01 17:02 Sample Weight: 1,000
Recording Time: 4.7.01 15:05 Sample Weight: 1,000
through the Minisart® (= overcomes the aqueous|organic solvents resto de líquido a través de Minisart® Minisart® SRP para la ultrapurificación de Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
bubble point). This procedure reduces the Minisart® SRP for ultracleaning of (= punto de burbuja superado). El volumen líquidos agresivos Injection Volume: 100,0 Injection Volume: 100,0
hold-up volume. aggressive liquids
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volumen muerto 5 μl 10 μl 100 μl 10 μl
Hold-up volume 5 μl 10 μl 100 μl 10 μl Conexiones LL/L LL/L LL/L LL/L
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Caja portafiltro Polipropileno Polipropileno Polipropileno Polipropileno
luer slip outlet luer slip outlet luer slip outlet luer slip outlet Membrana Celulosa Celulosa Celulosa Nylon
Housing Polypropylene Polypropylene Polypropylene Polypropylene
Membrane Cellulose Cellulose Cellulose Nylon Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
Volumen muerto 5 μl 10 μl 100 μl 100 μl
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Conexiones LL/L LL/L, o bien, LL/Spike LL/L LL/L
Hold-up volume 5 μl 10 μl 100 μl 100 μl Caja portafiltro Polipropileno Polipropileno Polipropileno Caja portafiltro
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Membrana PP reforzado PTFE PP reforzado PTFE PP reforzado PTFE Nylon Acetonitril Filtrat Acetonitril
luer slip outlet luer slip outlet luer slip outlet luer slip outlet
Housing Polypropylene (PP) Polypropylene (PP) Polypropylene (PP) Polypropylene CE
Minisart® SRP 0120 17575-ACK, en embalaje individual estéril. Sample Name: Acetonitril Channel: UV_VIS_4 Sample Name: Filtrat Acetonitril Channel: UV_VIS_4
Membrane PP-reinforced PTFE PP-reinforced PTFE PP-reinforced PTFE Nylon Vial Number: RA1 Wavelength: 280 Vial Number: RA2 Wavelength: 280
Aplicación para el venteo estéril, o bien para la filtración estéril de gases. Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
CE
Minisart® NY 17845-ACK; 17846-ACK, en embalaje individual estéril. Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
Minisart® SRP 0120 17575-ACK, individually steriled-packaged.
Recording Time: 5.7.01 14:13 Sample Weight: 1,000 Recording Time: 5.7.01 18:08 Sample Weight: 1,000
Designed for sterile venting or sterile filtration of gases. Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
®
Minisart NY 17845-ACK; 17846-ACK, individually steriled-packaged. Injection Volume: 100,0 Injection Volume: 100,0

Istruzioni per l’uso e dati del prodotto

Mode d’emploi et caractéristiques du produit
Versare il liquido da filtrare in una siringa attenzione con le siringhe con volume
provvista di attacco Luer. Montare minore di 10 ml, poiché la massima pressio-
Remplissez une seringue munie d’un inférieur à 10 ml. Avec ces seringues, on peut
sull’attacco Luer della siringa il dispositivo ne di rottura dell'housing di 6 bar può
embout Luer avec le liquide à filtrer. Placez rapidement dépasser la capacité de pression
di filtrazione Minisart® RC|SRP|NY. Filtrare essere facilmente superata. I dispositivi
le Minisart® RC|SRP|NY sur le raccord Luer maximale de 6 bars.
il contenuto della siringa in un recipiente Minisart® RC|SRP|NY devono essere usati
de la seringue. Filtrez le liquide contenu dans Veillez à n’utiliser chaque Minisart®
o in una apparecchiatura apposita. ogni volta solo per un campione per evitare
la seringue dans un flacon ou un appareil. RC|SRP|NY qu’une seule fois afin que le
il contaminazioni crociate.
liquide à filtrer ne soit pas en contact avec
Attenzione! Se si deve raggiungere il
Important ! Si vous souhaitez récupérer des restes d’échantillon.
recupero massimo del campione da Applicazione: Symbole In-Vitro-Diagnostika Sterilisation mit Dampf
le maximum de l’échantillon filtré, aspirez In-Vitro-Diagnostics sterilized, hot steam
filtrare, aspirare ancora una volta aria Minisart® RC per la purificazione di
une nouvelle fois de l’air dans la seringue Application: Nicht zur Wiederverwendung Dispositif médical de diagnostic Méthode de stérilisation utilisant
nella siringa dopo la filtrazione e spingere solventi acquosi|organici. Minisart® SRP
après la filtration et refoulez le liquide Minisart® RC est destiné à l’ultrapurifica- Single Use in vitro la vapeur ou la chaleur séche
il liquido rimanente attraverso Minisart® per la purificazione di liquidi aggressivi. Ne pas réutiliser Para uso en diagnóstico in vitro Esterilización por vapor caliente
restant à travers le Minisart® (= dépasse- tion de solvants aqueux |organiques.
(= superato il punto di bolla). In questo Minisart® NY per la filtrazione di soluzioni No reutilizable Per uso diagnostico in vitro Sterilizzazione con vapore caldo
ment du point de bulle). Cela réduit le Minisart® SRP est destiné à l’ultrapurifica- Monouso
modo il volume morto diminuisce. Fare alcaline.
volume mort. Faites attention lorsque vous tion de liquides corrosifs. verwendbar bis pyrogenfrei
travaillez avec des seringues d’un volume Bestellnummer Use before non-pyrogenic
Order Number Utiliser jusqu'au non pyrogène
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Référence du catalogue Fecha caducidad Apirógeno
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volume morto 5 μl 10 μl 100 μl 10 μl Número de referencia Data di scadenza Apirogeno
Volume mort 5 μl 10 μl 100 μl 10 μl Attacchi LL/L LL/L LL/L LL/L Codice d'ordine
Housing polipropilene polipropilene polipropilene polipropilene Chargenbezeichnung Porengröße
Raccords LL/L LL/L LL/L LL/L Lot Number Pore size
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante cellulosa cellulosa cellulosa Nylon Achtung! Code du lot Taille de pore
Membrane filtrante Cellulose Cellulose Cellulose Nylon Warning! Número de lote Tamaño de poro
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Attention! Numero di lotto Porosità
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Volume morto 5 μl 10 μl 100 μl 100 μl
Atención!
Volume mort 5 μl 10 μl 100 μl 100 μl Attenzione! Sterilisation mit Ethylenoxid Temperaturbegrenzung
Attacchi LL/L LL/L o LL/Spike LL/L LL/L sterilized, ETO maximum and minimum
Raccords LL/L LL/L ou LL/minipointe LL/L LL/L Housing polipropilene polipropilene polipropilene polipropilene Méthode de stérilisation util- temperature
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante PTFE rinforzato PTFE rinforzato PTFE rinforzato Nylon Hersteller isant de l'oxyde d'éthyléne Limite de température
Membrane filtrante PFTE renforcé PFTE renforcé PFTE renforcé Nylon con PP con PP con PP Manufacturer Esterilización por ETO Temperatura máxima y mínima
polypropyléne polypropyléne polypropyléne Fabricant Sterilizzazione con ETO Temperatura massima e minima
CE Fabricante
CE
Minisart® SRP 0120 17575-ACK, in confezione singola sterile. Produttore Sterilisation durch Bestrahlung
Minisart® SRP 0120 17575-ACK, en emballage individuel stérile. Utilizzo per l’aerazione sterile o la filtrazione sterile di gas. sterilized, irradiated
Utilisation pour la ventilation stérile ou la filtration stérile de gaz. ®
Minisart NY 17845-ACK; 17846-ACK, in confezione singola sterile. Méthode de stérilisation util-
®
Minisart NY 17845-ACK; 17846-ACK, en emballage individuel stérile. isant l'irradiation
Esterilización por radiación
Sterilizzazione per irradiazione
Directions for Use and Product Data Instrucciones de uso y datos de productos HPLC Certification
Fill a syringe, which has a luer connector, Take care when using syringes with a Llene con el líquido a filtrar una jeringa muerto se reduce. Tenga cuidado con las The membranes used with methanol|water and acetonitrile |water did not show any
with the liquid to be filtered. Attach the volume less than 10 ml, since they can easily con nonexión Luer. Coloque el filtro jeringas cuyo volumen es menor que 10 ml; artifacts or interference peaks in the range of 200–300 mm during HPLC.
Minisart® RC|SRP|NY to the luer connector generate a pressure greater than the burst Minisart® RC|SRP|NY en la conexión Luer aquí se supera rápidamente la resistencia
on the syringe. Filter the contents of the pressure rating for Minisart® housings. de la jeringa. Filtre el contenido de la a la presión de 6 bar.
syringe into a flask or apparatus. Use Minisart® RC|SRP|NY for a single jeringa en un recipiente o dispositivo. Utilice Minisart® RC|SRP|NY sólo para una Methanol Filtrat Methanol
sample only to avoid carrying over residues muestra, para evitar en forma segura el
Important Note! If you need to ensure of one sample to the next one. Advertencia: Si ha de alcanzarse la máxi- arrastre de residuos de la muestra anterior. Sample Name: Methanol Channel: UV_VIS_2 Sample Name: Filtrat Methanol Channel: UV_VIS_2
maximum recovery of the sample, draw air ma recuperación de la muestra a filtrar, Aplicaciones: Vial Number: RA3 Wavelength: 214 Vial Number: RA4 Wavelength: 214
Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
into the syringe after filtration and press Applications: succione aire en la jeringa una vez más, Minisart® RC para la ultrapurificación de
Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
in the plunger to filter the residual liquid Minisart® RC for ultracleaning of después de la filtración, y luego presione el disolventes acuosos|orgánicos. Recording Time: 4.7.01 17:02 Sample Weight: 1,000
Recording Time: 4.7.01 15:05 Sample Weight: 1,000
through the Minisart® (= overcomes the aqueous|organic solvents resto de líquido a través de Minisart® Minisart® SRP para la ultrapurificación de Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
bubble point). This procedure reduces the Minisart® SRP for ultracleaning of (= punto de burbuja superado). El volumen líquidos agresivos Injection Volume: 100,0 Injection Volume: 100,0
hold-up volume. aggressive liquids
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volumen muerto 5 μl 10 μl 100 μl 10 μl
Hold-up volume 5 μl 10 μl 100 μl 10 μl Conexiones LL/L LL/L LL/L LL/L
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Caja portafiltro Polipropileno Polipropileno Polipropileno Polipropileno
luer slip outlet luer slip outlet luer slip outlet luer slip outlet Membrana Celulosa Celulosa Celulosa Nylon
Housing Polypropylene Polypropylene Polypropylene Polypropylene
Membrane Cellulose Cellulose Cellulose Nylon Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
Volumen muerto 5 μl 10 μl 100 μl 100 μl
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Conexiones LL/L LL/L, o bien, LL/Spike LL/L LL/L
Hold-up volume 5 μl 10 μl 100 μl 100 μl Caja portafiltro Polipropileno Polipropileno Polipropileno Caja portafiltro
Connectors Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Luer lock inlet/ Membrana PP reforzado PTFE PP reforzado PTFE PP reforzado PTFE Nylon Acetonitril Filtrat Acetonitril
luer slip outlet luer slip outlet luer slip outlet luer slip outlet
Housing Polypropylene (PP) Polypropylene (PP) Polypropylene (PP) Polypropylene CE
Minisart® SRP 0120 17575-ACK, en embalaje individual estéril. Sample Name: Acetonitril Channel: UV_VIS_4 Sample Name: Filtrat Acetonitril Channel: UV_VIS_4
Membrane PP-reinforced PTFE PP-reinforced PTFE PP-reinforced PTFE Nylon Vial Number: RA1 Wavelength: 280 Vial Number: RA2 Wavelength: 280
Aplicación para el venteo estéril, o bien para la filtración estéril de gases. Sample Type: unknown Bandwith: 1 Sample Type: unknown Bandwith: 1
CE
Minisart® NY 17845-ACK; 17846-ACK, en embalaje individual estéril. Quantif. Method: DXtest Dilution Factor: 1,000 Quantif. Method: DXtest Dilution Factor: 1,000
Minisart® SRP 0120 17575-ACK, individually steriled-packaged.
Recording Time: 5.7.01 14:13 Sample Weight: 1,000 Recording Time: 5.7.01 18:08 Sample Weight: 1,000
Designed for sterile venting or sterile filtration of gases. Run Time (min.): 58,00 Sample Amount: 1,000 Run Time (min.): 58,00 Sample Amount: 1,000
®
Minisart NY 17845-ACK; 17846-ACK, individually steriled-packaged. Injection Volume: 100,0 Injection Volume: 100,0

Istruzioni per l’uso e dati del prodotto

Mode d’emploi et caractéristiques du produit
Versare il liquido da filtrare in una siringa attenzione con le siringhe con volume
provvista di attacco Luer. Montare minore di 10 ml, poiché la massima pressio-
Remplissez une seringue munie d’un inférieur à 10 ml. Avec ces seringues, on peut
sull’attacco Luer della siringa il dispositivo ne di rottura dell'housing di 6 bar può
embout Luer avec le liquide à filtrer. Placez rapidement dépasser la capacité de pression
di filtrazione Minisart® RC|SRP|NY. Filtrare essere facilmente superata. I dispositivi
le Minisart® RC|SRP|NY sur le raccord Luer maximale de 6 bars.
il contenuto della siringa in un recipiente Minisart® RC|SRP|NY devono essere usati
de la seringue. Filtrez le liquide contenu dans Veillez à n’utiliser chaque Minisart®
o in una apparecchiatura apposita. ogni volta solo per un campione per evitare
la seringue dans un flacon ou un appareil. RC|SRP|NY qu’une seule fois afin que le
il contaminazioni crociate.
liquide à filtrer ne soit pas en contact avec
Attenzione! Se si deve raggiungere il
Important ! Si vous souhaitez récupérer des restes d’échantillon.
recupero massimo del campione da Applicazione: Symbole In-Vitro-Diagnostika Sterilisation mit Dampf
le maximum de l’échantillon filtré, aspirez In-Vitro-Diagnostics sterilized, hot steam
filtrare, aspirare ancora una volta aria Minisart® RC per la purificazione di
une nouvelle fois de l’air dans la seringue Application: Nicht zur Wiederverwendung Dispositif médical de diagnostic Méthode de stérilisation utilisant
nella siringa dopo la filtrazione e spingere solventi acquosi|organici. Minisart® SRP
après la filtration et refoulez le liquide Minisart® RC est destiné à l’ultrapurifica- Single Use in vitro la vapeur ou la chaleur séche
il liquido rimanente attraverso Minisart® per la purificazione di liquidi aggressivi. Ne pas réutiliser Para uso en diagnóstico in vitro Esterilización por vapor caliente
restant à travers le Minisart® (= dépasse- tion de solvants aqueux |organiques.
(= superato il punto di bolla). In questo Minisart® NY per la filtrazione di soluzioni No reutilizable Per uso diagnostico in vitro Sterilizzazione con vapore caldo
ment du point de bulle). Cela réduit le Minisart® SRP est destiné à l’ultrapurifica- Monouso
modo il volume morto diminuisce. Fare alcaline.
volume mort. Faites attention lorsque vous tion de liquides corrosifs. verwendbar bis pyrogenfrei
travaillez avec des seringues d’un volume Bestellnummer Use before non-pyrogenic
Order Number Utiliser jusqu'au non pyrogène
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Référence du catalogue Fecha caducidad Apirógeno
Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15 Volume morto 5 μl 10 μl 100 μl 10 μl Número de referencia Data di scadenza Apirogeno
Volume mort 5 μl 10 μl 100 μl 10 μl Attacchi LL/L LL/L LL/L LL/L Codice d'ordine
Housing polipropilene polipropilene polipropilene polipropilene Chargenbezeichnung Porengröße
Raccords LL/L LL/L LL/L LL/L Lot Number Pore size
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante cellulosa cellulosa cellulosa Nylon Achtung! Code du lot Taille de pore
Membrane filtrante Cellulose Cellulose Cellulose Nylon Warning! Número de lote Tamaño de poro
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Attention! Numero di lotto Porosità
Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25 Volume morto 5 μl 10 μl 100 μl 100 μl
Atención!
Volume mort 5 μl 10 μl 100 μl 100 μl Attenzione! Sterilisation mit Ethylenoxid Temperaturbegrenzung
Attacchi LL/L LL/L o LL/Spike LL/L LL/L sterilized, ETO maximum and minimum
Raccords LL/L LL/L ou LL/minipointe LL/L LL/L Housing polipropilene polipropilene polipropilene polipropilene Méthode de stérilisation util- temperature
Corps de filtre Polypropylène Polypropylène Polypropylène Polypropylène Membrana filtrante PTFE rinforzato PTFE rinforzato PTFE rinforzato Nylon Hersteller isant de l'oxyde d'éthyléne Limite de température
Membrane filtrante PFTE renforcé PFTE renforcé PFTE renforcé Nylon con PP con PP con PP Manufacturer Esterilización por ETO Temperatura máxima y mínima
polypropyléne polypropyléne polypropyléne Fabricant Sterilizzazione con ETO Temperatura massima e minima
CE Fabricante
CE
Minisart® SRP 0120 17575-ACK, in confezione singola sterile. Produttore Sterilisation durch Bestrahlung
Minisart® SRP 0120 17575-ACK, en emballage individuel stérile. Utilizzo per l’aerazione sterile o la filtrazione sterile di gas. sterilized, irradiated
Utilisation pour la ventilation stérile ou la filtration stérile de gaz. ®
Minisart NY 17845-ACK; 17846-ACK, in confezione singola sterile. Méthode de stérilisation util-
®
Minisart NY 17845-ACK; 17846-ACK, en emballage individuel stérile. isant l'irradiation
Esterilización por radiación
Sterilizzazione per irradiazione
 Sartorius Stedim Biotech GmbH
85030-538-37 Minisart®-RC|SRP|NY
Certificate for August-Spindler-Strasse 11
®
Minisart-RC|SRP|NY 37079 Goettingen, Germany
www.sartorius-stedim.com Gebrauchsanweisung und Produktdaten
The purpose of this Certificate is to provide information about Sartorius Stedim Biotech Füllen Sie die zu filtrierende Flüssigkeit Vorsicht bei Spritzen mit einem Volumen
Specifications subject to change without notice.
products’ compliance with quality standards. Sartorius Stedim Biotech certifies that its Printed and copyrighted by Sartorius Stedim Biotech GmbH in eine Spritze mit Luer Anschluss. Setzen kleiner als 10 ml. Hierbei wird die maximale
products listed below meet the high quality requirements placed on them. W106.07 Publication No.: SL-6154-p09061 Sie den Minisart® RC|SRP|NY auf den Luer- Druckbelastbarkeit von 6 bar schnell
Ver. 06 | 2009 Anschluss der Spritze. Filtrieren Sie den überschritten.
Product Catalog No. Inhalt der Spritze in ein Gefäß bzw. eine Minisart® RC|SRP|NY jeweils nur für eine
Apperatur. Probe benutzen, um eine Verschleppung
Minisart® RC: von Proberesten sicher zu vermeiden.
17821; 17822; 17761; 17762; 17764; 17765 Achtung! Wenn die maximale Rückgewin-
nung der zu filtrierenden Probe erreicht Application:
Minisart® SRP: werden soll ziehen Sie nach der Filtration Minisart® RC zur Hochreinigung von
17820; 17558; 17559; 17573; 17574; 17575; 17576 noch einmal Luft in die Spritze und wässrigen|organischen Lösungsmitteln
drücken Sie die Restflüssigkeit durch den Minisart® SRP zur Hochreinigung von
Minisart® NY: Minisart® (=Bubble Point überwunden). aggressiven Flüssigkeiten.
Das Totvolumen reduziert sich.
17845; 17846, 1776 B, 1776 C
I. Good Manufacturing Practice Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
These products have been manufactured in a Sartorius Stedim Biotech facility in Totvolumen 5 μl 10 μl 100 μl 10 μl
compliance with the FDA regulations and Good Manufacturing Practice standards. Anschlüsse LL/L LL/L LL/L LL/L
Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
II. 100% Tested during Manufacture Membran Cellulose Cellulose Cellulose Nylon
Each unit is tested for membrane and housing integrity during manufacture. Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
III. Quality Assurance Lot Release Criteria Totvolumen 5 μl 10 μl 100 μl 100 μl
Anschlüsse LL/L LL/L bzw. LL/Spike LL/L LL/L
Each manufacturing lot has been tested and released according to the following Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
in-house criteria: Bubble point, housing integrity, flow rate for water or ethanol Membran PP verstärktes PTFE PP verstärktes PTFE PP verstärktes PTFE Nylon
IV. HPLC Certification CE
Minisart® SRP 0120 17575-ACK, einzeln steril verpackt.
The membranes used with methanol/water and acetonitrile/water did not show Anwendung zur Sterilbelüftung oder Sterilfiltration von Gasen, auch für medizinische
any artifacts or interference peaks in the range of 200 – 300 nm during HPLC. Zwecke.
Minisart® NY 17845-ACK; 17846-ACK, einzeln steril verpackt.
V. Sartorius Stedim Biotech has been certified for compliance with ISO 9001.

Dr. Ralf Wawotzny

Director of Quality Filtration Products
 Sartorius Stedim Biotech GmbH
85030-538-37 Minisart®-RC|SRP|NY
Certificate for August-Spindler-Strasse 11
®
Minisart-RC|SRP|NY 37079 Goettingen, Germany
www.sartorius-stedim.com Gebrauchsanweisung und Produktdaten
The purpose of this Certificate is to provide information about Sartorius Stedim Biotech Füllen Sie die zu filtrierende Flüssigkeit Vorsicht bei Spritzen mit einem Volumen
Specifications subject to change without notice.
products’ compliance with quality standards. Sartorius Stedim Biotech certifies that its Printed and copyrighted by Sartorius Stedim Biotech GmbH in eine Spritze mit Luer Anschluss. Setzen kleiner als 10 ml. Hierbei wird die maximale
products listed below meet the high quality requirements placed on them. W106.07 Publication No.: SL-6154-p09061 Sie den Minisart® RC|SRP|NY auf den Luer- Druckbelastbarkeit von 6 bar schnell
Ver. 06 | 2009 Anschluss der Spritze. Filtrieren Sie den überschritten.
Product Catalog No. Inhalt der Spritze in ein Gefäß bzw. eine Minisart® RC|SRP|NY jeweils nur für eine
Apperatur. Probe benutzen, um eine Verschleppung
Minisart® RC: von Proberesten sicher zu vermeiden.
17821; 17822; 17761; 17762; 17764; 17765 Achtung! Wenn die maximale Rückgewin-
nung der zu filtrierenden Probe erreicht Application:
Minisart® SRP: werden soll ziehen Sie nach der Filtration Minisart® RC zur Hochreinigung von
17820; 17558; 17559; 17573; 17574; 17575; 17576 noch einmal Luft in die Spritze und wässrigen|organischen Lösungsmitteln
drücken Sie die Restflüssigkeit durch den Minisart® SRP zur Hochreinigung von
Minisart® NY: Minisart® (=Bubble Point überwunden). aggressiven Flüssigkeiten.
Das Totvolumen reduziert sich.
17845; 17846, 1776 B, 1776 C
I. Good Manufacturing Practice Minisart® RC4 Minisart® RC15 Minisart® RC25 Minisart® NY15
These products have been manufactured in a Sartorius Stedim Biotech facility in Totvolumen 5 μl 10 μl 100 μl 10 μl
compliance with the FDA regulations and Good Manufacturing Practice standards. Anschlüsse LL/L LL/L LL/L LL/L
Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
II. 100% Tested during Manufacture Membran Cellulose Cellulose Cellulose Nylon
Each unit is tested for membrane and housing integrity during manufacture. Minisart® SRP4 Minisart® SRP15 Minisart® SRP25 Minisart® NY25
III. Quality Assurance Lot Release Criteria Totvolumen 5 μl 10 μl 100 μl 100 μl
Anschlüsse LL/L LL/L bzw. LL/Spike LL/L LL/L
Each manufacturing lot has been tested and released according to the following Gehäuse Polypropylen Polypropylen Polypropylen Polypropylen
in-house criteria: Bubble point, housing integrity, flow rate for water or ethanol Membran PP verstärktes PTFE PP verstärktes PTFE PP verstärktes PTFE Nylon
IV. HPLC Certification CE
Minisart® SRP 0120 17575-ACK, einzeln steril verpackt.
The membranes used with methanol/water and acetonitrile/water did not show Anwendung zur Sterilbelüftung oder Sterilfiltration von Gasen, auch für medizinische
any artifacts or interference peaks in the range of 200 – 300 nm during HPLC. Zwecke.
Minisart® NY 17845-ACK; 17846-ACK, einzeln steril verpackt.
V. Sartorius Stedim Biotech has been certified for compliance with ISO 9001.

Dr. Ralf Wawotzny

Director of Quality Filtration Products