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Elevated Assurance Program

Elevate - Higher quality peaks diagnostic expectations

Elevated Assurance Program – Your raw material partner in manufacturing

In today’s regulated environment, you face increasing demands for compliance with stringent requirements. Partnering with a raw material supplier like us can make a significant difference as you prepare for future regulatory changes. We offer raw materials qualified for manufacturing, complete with documentation and quality services.

Our Elevated Assurance Program instills confidence as you navigate this complex landscape. We provide the necessary documentation to support your audits and risk assessments. Products in this program support your needs for supply chain transparency, as well as manufacturing and quality controls. Additionally, products have the attributes of a M-Clarity™ quality segment of MQ300 or higher as shown in the table below.

By choosing our Elevated Assurance Program, you can count on enhanced support and exceptional quality-related information. Together, we will ensure you are well-equipped to meet your internal and external quality standards.

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Audit-Readiness Benefits - Demonstrate Your Commitment to High-Quality Products

Confirmed process controls to ensure consistency
Enhanced change notification
Risk assessment documentation (certificates, impurity profiles and declarations)
Robust, ready-to-present dossier

Dossier Content Available Free of Charge:

Site quality assessment
ISO 9001 certificate
Product specifications
Declarations/statements (animal origin content, BSE/TSE, nitrosamine, may vary depending on product group)

MQ300 Level or Higher Products Launched in the Elevated Assurance Program

Upgrading our products to meet quality standards of MQ300 and above will raise the bar in support and services that we provide our customers.

Proteins

Description	1 g	10 x 1 g	5 g	500 mg	15 mL	50 mL	250 mL	1000 mL
Proteinase K from Tritirachium album, buffered aqueous glycerol solution, ≥800 units/ml					SRE0005-15ML		SRE0005-250ML
Trypsin Inhibitor from Glycine max (soybean), suitable for cell culture			SRE0044-5G
Proteinase K from Tritirachium album, buffered aqueous glycerol solution, ≥800 units/ml	SRE0047-1G			SRE0047-500MG
Aprotinin from Bovine Lung, saline solution, 3-7 TIU/mg protein						SRE0050-50ML		SRE0050-1000ML
Aprotinin from Bovine Lung, lyophilized powder, ≥3 TIU/mg solid	SRE0078-1G	SRE0078-10x1G					SRE0078-250MG

Description	Large-Scale	60 KU	300 KU	500 KU	550 KU	1 MU	10 MU
Proteinase K from Tritirachium album, buffered aqueous glycerol solution, ≥800 units/ml	Request a Bulk Order
Thymidine Phosphorylase, recombinant from Escherichia coli	Request a Bulk Order					SRE0006-1MU
Lyticase from Arthrobacter Luteus					SRE0018-550KU
Butyrylcholinesterase from equine serum, ≥900 units/mg protein		SRE0020-60KU
Heparin sodium porcine mucosa	Request a Bulk Order			SRE0027-500KU		SRE0027-1MU	SRE0027-10MU
Trypsin Inhibitor from Glycine max (soybean), suitable for cell culture	Request a Bulk Order
Proteinase K from Tritirachium album, buffered aqueous glycerol solution, ≥800 units/ml	Request a Bulk Order
Aprotinin from Bovine Lung, saline solution, 3-7 TIU/mg protein	Request a Bulk Order
Aprotinin from Bovine Lung, lyophilized powder, ≥3 TIU/mg solid	Request a Bulk Order
Peroxidase from Horseradish, lyophilized powder, 250 units/mg solid (using pyrogallol)	Request a Bulk Order		SRE0082-300KU	SRE0082-5000KU		SRE0082-1000KU

For more information, contact our experts!

Buffers

Description	5 kg	10 kg	25 kg	50 kg	Large-Scale
BIS-TRIS, BioPerformance Certified, suitable for cell culture, suitable for insect cell culture, ≥98.0%					Request a Bulk Order
BIS-TRIS propane, ≥99.0% (titration)		B6755-10KG			Request a Bulk Order
Guanidine hydrochloride, for molecular biology, ≥99%		G3272-10KG			Request a Bulk Order
Guanidine hydrochloride, organic base and chaeotropic agent, ≥99% (titration)		G4505-10KG	G4505-25KG		Request a Bulk Order
HEPES, BioPerformance Certified, ≥99.5% (titration), suitable for cell culture			H4034-25KG		Request a Bulk Order
MES hydrate, BioPerformance Certified, suitable for cell culture, ≥99.5%		M2933-10KG			Request a Bulk Order
MES sodium salt, BioPerformance Certified, suitable for cell culture		M3058-10KG			Request a Bulk Order
MOPS, BioXtra, ≥99.5% (titration)					Request a Bulk Order
MES hydrate, ≥99.5% (titration)			M8250-25KG	M8250-50KG	Request a Bulk Order
MOPS sodium salt, BioPerformance Certified, suitable for cell culture, ≥99.5%					Request a Bulk Order
Tricine, ≥99% (titration)	T0377-5KG		T0377-25KG		Request a Bulk Order
Trizma^® hydrochloride, reagent grade, ≥99.0% (titration), crystalline		T3253-10KG	T3253-25KG	T3253-50KG	Request a Bulk Order
Trizma^® base, ≥99.9% (titration), crystalline					Request a Bulk Order
Trizma^® hydrochloride, BioPerformance Certified, suitable for cell culture, ≥99.0% (titration)	T5941-5KG	T5941-10KG			Request a Bulk Order
Trizma^® base, BioPerformance Certified, meets EP, USP testing specifications, suitable for cell culture, ≥99.9% (titration)	T6066-5KG	T6066-10KG			Request a Bulk Order

For more information, contact our experts!

Bovine Serum Albumin

Description	10 g	100 g	1 kg	5 kg	50 mL	1 L
Probumin^® Universal Grade	81003N	810033	810037	810036
Probumin^® Diagnostic Grade	820453	820451	820452	820456	820464	820463
Probumin^® Fatty Acid Free		820024	820027	820026
Probumin^® Life Science Grade		821006	821001	821005

For more information, contact our experts!

White and Dyed Microsphere Beads

Description	0.5 g	1 g	5 g	10 g	100 g	1 kg
K-007 White Std PS 10%		FR139431081-1		FR139431081-10	FR139431081-100	FR139431081-1000
K-010 White Std PS 10%		FR139469081-1		FR139469081-10	FR139469081-100	FR139469081-1000
K-015 White Std PS 10%		FR127712084-1		FR127712084-10	FR127712084-100	FR127712084-1000
K-020 White Std PS 10%		FR139430087-1		FR139430087-10	FR139430087-100	FR139430087-1000
K-030 White Std PS 10%		FR123690087-1		FR123690087-10	FR123690087-100	FR123690087-1000
K-080 White Std PS 10%		FR123692084-1		FR123692084-10	FR123692084-100	FR123692084-1000
K1-010 White COOH PS 10%		FR139491087-1		FR139491087-10	FR139491087-100	FR139491087-1000
K1-030 White COOH PS 10%		FR180380014-1		FR180380014-10	FR180380014-100	FR180380014-1000
K1-040 White COOH PS 10%		FR180380592-1		FR180380592-10	FR180380592-100	FR180380592-1000
K1-050 White COOH PS 10%		FR139424086-1		FR139424086-10	FR139424086-100	FR139424086-1000
K1-080 White COOH PS 10%		FR123696087-1		FR123696087-10	FR123696087-100	FR123696087-1000
KSF-010 White Std PS 10%		FR180380104-1		FR180380104-10	FR180380104-100	FR180380104-1000
KSF-015 White Std PS 10%		FR180380103-1		FR180380103-10	FR180380103-100	FR180380103-1000
PSI-90-21 White COOH PS 10%		FR180380012-1		FR180380012-10	FR180380012-100	FR180380012-1000
A1-005 White COOH PS AV 10%		FR180380018-1		FR180380018-10	FR180380018-100	FR180380018-1000
A1-010 White COOH PS AV 10%		FR180380020-1		FR180380020-10	FR180380020-100	FR180380020-1000
IT-250 White COOH PS 10%		FR180380626-1		FR180380626-10	FR180380626-100	FR180380626-1000
K1-030 Blue Int COOH PS 5%	FR180380642-05	FR180380642-1	FR180380642-5	FR180380642-10
K1-030 Red Int COOH PS 5%	FR180380637-05	FR180380637-1	FR180380637-5	FR180380637-10
K1-040 Blue Int COOH PS 5%	FR180380641-05	FR180380641-1	FR180380641-5	FR180380641-10
K1-040 Red Int COOH PS 5%	FR180380638-05	FR180380638-1	FR180380638-5	FR180380638-10

For more information, contact our experts!

Fluoroscent Microsphere Beads

Description	0.1 g	1 g	10 g
F1-EU-010 FluoEU COOH PS 1%	FR180380623-01	FR180380623-1	FR180380623-10
F1-EU-030 FluoEU COOH PS 1%	FR180380624-01	FR180380624-1	FR180380624-10
F1-EU-050 FluoEU COOH PS 1%	FR180380625-01	FR180380625-1	FR180380625-10
F1-XC-010 FluoXC COOH PS 1%	FR139376080-01	FR139376080-1
F1-XC-030 FluoXC COOH PS 1%	FR139414082-01	FR139414082-1
F1-XC-040 FluoXC COOH PS 1%	FR180380531-01	FR180380531-1
F1-XC-050 FluoXC COOH PS 1%	FR180380535-01	FR180380535-1

For more information, contact our experts!

Magnetic Microsphere Beads

Description	0.5 g	1 g	10 g	100 g	1 kg
EM1-100/40 Mag COOH PS 10%	FR123710087-05	FR123710087-1	FR123710087-10	FR123710087-100	FR123710087-1000
EM2-100/40 Mag NH2 PS 10% 0,5 G to 1000 G	FR139572001-05	FR139572001-1	FR139572001-10	FR139572001-100	FR139572001-1000
M1-020/50 Mag COOH PS 10% 1 G to 1000 G		FR180380073-1	FR180380073-10	FR180380073-100	FR180380073-1000
M1-030/40 Mag COOH PS 10% 1 G to 1000 G		FR180380000-1	FR180380000-10	FR180380000-100	FR180380000-1000
M1-070/40 Mag COOH PS 10% 0,5 G to 1000 G	FR123709083-05	FR123709083-1	FR123709083-10	FR123709083-100	FR123709083-1000
M1-070/60 Mag COOH PS 10% 0,5 G to 1000 G	FR123711081-05	FR123711081-1	FR123711081-10	FR123711081-100	FR123711081-1000
MS-070/40 Mag PS 10% 1 G to 1000 G		FR180380074-1	FR180380074-10	FR180380074-100	FR180380074-1000

For more information, contact our experts!

Preservatives

Pack Size	ProClin™ 150	ProClin™ 200	ProClin™ 300	ProClin™ 950
1 x 5 mL ampule			48934-U	46885-U
50 mL bottle	49376-U	48171-U	48912-U	46878-U
400 mL bottle	49377-U		48914-U	46879-U
2 L bottle			48915-U
3.6 L bottle	49378-U		48917-U	46883-U
15 L pail	49379-U
17 L pail				46884-U
18 L pail			48918-U
91.7 L drum (110 KG)	49380-U		48919-U

For more information, contact our experts!

Quality standards and attributes for MQ300 Level and Higher materials in the Elevated Assurance Program

Discriminating Attributes	Raw Materials
Quality Standards	ISO 9001
Specifications Available	✓
Certification of Quality or Certificate of Analysis available	✓
Release testing- performed using established protocols	✓
Written SOP for process control	✓
Enhanced Change Notification	✓
Site quality self-assessment available	✓
Physical audits can be requested by customer	✓
Product can be added to the Quality Agreement	✓
Quality declarations as required by regulation or product application	✓
Process control verified	✓
Supplier approval by paper audit and questionnaire	✓
Supplier approval by on-site audit for critical suppliers, as applicable	✓
Shelf-life/Expiration date is defined by stability study	✓
Intended Use Statement. For Manufacturing Use	✓
Compliance Certificate REACH, RoHS, Conflict Materials, Animal Origin, etc.	✓
Product can be added to Pricing & Supply Agreement	✓
Country of Origin identified	✓

You asked, We listened

The seal should assure you of product quality. Here’s the meaning behind the design:

Mountain ranges go from low to high showing our elevation in high quality products and services.
The check mark, in both the mountain range and negative space, represents the verification and scrutiny the products will go through to make sure the proper documentation and support is ready for customer audits/needs.
The three peaks indicate our ever-extending offering within the Elevated Assurance Program.

Related Resources

Brochure: ProClin™ Biocidal Preservatives
ProClin™ preservatives enhance shelf life in over 1,000 FDA-registered IVD kits by inhibiting a wide range of microbes effectively.
Flyer: For In Vitro Diagnostic Materials: Efficacy vs. Thimerosal and Sodium Azide
Efficacy vs. Thimerosal and Sodium Azide: Traditional preservatives like thimerosal and sodium azide are costly, toxic, and less effective against microbes in in vitro diagnostics.
Flyer: ProClin™ Preservatives: Questions Addressing Regulatory Concerns
Questions Addressing Regulatory Concerns: ProClin™ products serve the global Medical Devices and IVD sectors, exempt from Biocidal Products Regulation when compliant with relevant directives.
Flyer: Probumin^® Bovine Serum Albumin (BSA)
Albumin is vital in diagnostics, offering stability and binding capabilities. We provide consistent bovine serum albumin with 65 years of expertise.

Online Dossier Available Free of Charge From Product Page

ProClin™
Probumin^®
Buffers
Proteins
Amino Acids

Carbohydrates
Detergents/Denaturants
High-purity Solvents
Catalysts

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