USP 61 Accredited Testing Labs Worldwide
34 accredited laboratories in 6 countries hold USP 61 in their ISO/IEC 17025 scope. Primary accreditors include American Association for Laboratory Accreditation, Deutsche Akkreditierungsstelle, Comité français d'accréditation. In the register, USP 61 scope entries most often cover Aerobic Plate Count, Total Coliforms, Germes Aérobies Viables Totaux in Drinking water, Pharmaceuticals, Medical devices.
Available in 6 Countries
Top matrices for USP 61
Top analytes for USP 61
- Aerobic Plate Count (2)
- Total Coliforms (2)
- Germes Aérobies Viables Totaux (2)
- Burkholderia Cepacia Complex (1)
- Enumeration Of Viable Aerobic Germs (1)
- Escherichia Coli (1)
- Endotoxin (1)
- Fungal Spores (1)
Sample labs
PORTEE FLEX 1 # ENVIRONNEMENT / QUALITE DE L’EAU / Analyses microbiologiques (Analyses microbiologiques des eaux – LAB GTA 23) OBJET CARACTERISTIQUE MESUREE OU RECHERCHEE PRINCIPE DE LA METHODE REFERENCE DE LA METHODE Eaux des étab
Test(s): Test Method(s): Elution USP <87> USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993- 12 Biological LAL Bacterial Endotoxins USP <85> and <161>; ANSI/AAMI ST72:2011. EP 2.6.14, Bacterial Endo toxins Microbiolo
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 ELEMENT MATERIALS TECHNOLOGY BOSTON – ACTON INC. 33 Nagog Park Acton, MA 01720 Mr. Mark W Przybyla Phone: 978 393-4095 Mark.Przybyla@element.com BIOLOGICAL Valid To: Ja
PRODUITS CHIMIQUES ET BIOLOGIQUES / PRODUITS BIO-ACTIFS / Analyses microbiologiques (Analyses microbiologiques appliquées aux produits pharmaceutiques et cosmétiques– LAB GTA 19) OBJET CARACTERISTIQUE MESUREE OU RECHERCHEE PRINCIPE DE
Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Pharmazeutisch - technologische Prüfungen Stoffe als integrale Bestandteile mit unterstützender Funktion von Medizinprodukten nach Ar
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 STERIS LABORATORIES, INC. 9303 West Broadway Ave Brooklyn Park MN, 55445 Beth Jacques Phone: 763-315-1200 BIOLOGICAL Valid To: January 31, 2027
(A2LA Cert No. 4873.03) 04/28/2025 Page 1 of 2 Enumeration of Indicators by 3M Petrifilm Aerobic count PAT-AM-005 (Dried Cannabis and Its Products); MFHPB-33 E. coli/ Coliforms PAT-AM-006 (Dried Cannabis and Its Products); MFHPB-34 E
Datum 2025-09-26 2024/1308 Bilaga 1 Mikrobiologisk analys Teknikområde Parameter Metod Mätprincip Provtyp Flex Typ av flex Anmärkning Totalantal aeroba mikroorganismer, kvantitativ, ingjutning SS-EN ISO 11737-1 Medicintekniska produkte
Test Reference Method(s) SOP(s) *Environmental Monitoring Testing USP <797> USP <1116> ISO 14644-1 ISO 14644-2 EM-0002 EM-0009 EM-0013 EM-0015 Growth Promotion and Sterility Testing of Microbiological Media USP <61> USP <62>
USP 61 Yeast & Mold QA-0035-0501 CMMEF Ch. 21.51 FDA BAM Ch. 18 (7th Ed.) Yeast & Mold, Osmophilic QA-0035-0502 CMMEF 5th ed. Ch. 17.3 Yeast & Mold Petrifilm™, Rapid QA-0035-0595 AOAC 2014.05 Yeast and Mols - USP QA-0050-0629 USP 61
Portée FLEX 1 : PRODUITS CHIMIQUES ET BIOLOGIQUES / PRODUITS BIO-ACTIFS / ANALYSES MICROBIOLOGIQUES (Analyses microbiologiques appliquées aux produits pharmaceutiques et cosmétiques– LAB GTA 19) OBJET CARACTERISTIQUE MESUREE OU RECHERCH
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 MARSIL LABORATORIES LLC 3816 North Meridian Avenue, Suite 113 Oklahoma City, OK 73112 Dr. Oluyomi Ajibode, Ph.D. Phone: (405) 917-5517 BIOLOGICAL Valid To: August 31, 2027
SCOPE OF ACCREDITATION TO ISO/IEC 17025:20 17 EUROFINS MICROBIOLOGY LABORATORIES, INC. – MADISON 6304 Ronald Reagan Ave. Madison, WI 53704-2523 Kyle McCartney Phone: 608-210-5413 BIOLOGICAL Valid To: October 31, 2
Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485: 20212, Abs. 6.4 und Abs. 7.5 Chemisch
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 TENTAMUS CALIFORNIA 133 Technology Dr Ste 150 Irvine, CA 92618-2476 Alex Kiddle Phone: 858-750-2146 Alex.Kiddle@Tentamus.com BIOLOGICAL Valid To: May 31, 2027
Preservatives by HPLC-UV / DAD (Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Methylparaben, Chlorophenesin, Ethylparaben, Isopropylparaben, Propylparaben, Isobutylparaben, Butylparaben) CAM 9241 USP<631> - Liquid Chromatograp
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 ALS GROUP USA, CORP. 3904 Del Amo Blvd. Suite 801 Torrance, CA 90503 Eileen Camacho Phone: 310-214-0043 CHEMICAL Valid To: September 30, 2026
Testing field Test item Device (category) Type of testing Test Regulation Testing method Microbiological- hygienic tests Medical devices Sterility testing DIN EN ISO 11737-2 Ph. Eur. 2.6.1 SOP 09-012 Counting of the total repro
Testing area Test item device (category) Type of testing test Regulation testing method Environmental monitoring in the manufacture and testing of the cleanliness of the products in accordance with DIN EN ISO 13485: 2021 1, para. 6.
Test(s)/Technology(ies) Test Method(s) Spiroxamine Tebuconazole Thiacloprid Thiamethoxam Trifloxystrobin Mycotoxins by LC-MS/MS Aflatoxin B1 Aflatoxin B2 Aflatoxin G1 Aflatoxin G2 Ochratoxin SOP-070-VA Pesticides and Mycotox
Portée FLEX1 PRODUITS CHIMIQUES ET BIOLOGIQUES / PRODUITS BIO-ACTIFS / ANALYSES MICROBIOLOGIQUES (Analyses microbiologiques appliquées aux produits pharmaceutiques et cosmétiques - LAB GTA 19) OBJET CARACTERISTIQUE MESUREE OU RECHERCH
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 ARL BIOPHARMA, INC. D.B.A ANALYTICAL RESEARCH LABORATORIES (ARL) 840 Research Parkway, Ste. 546 Oklahoma City, OK 73104 Tommy Means Phone: 405-271-1144 CHEMICAL Valid T
Anlage zur Teil-Akkreditierungsurkuncle D-PL-14115-02-07 DAkkS Deutsche Akkreditierungsstelle Norm / Ausgabedatum Hausmethode / Version Analyt — Titel der Norm Angabe zu Probenvorbehandlung/Prüftechnik Prüfgegenstand SOP M 1227 2019-09 Best
Test(s) Analyte(s) Method(s) Direct Microscope Examination (DME) Microscopic Examination of Fungal Spores, Fungal Structures, Hyphae, Pollen, Insect Fragments, and Fibrous Material from Surface Samples ASTM D7658-17 MIC 02 Mycobacter
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 PHARMETRIC LABORATORY 7265 Ulmerton Rd Largo, FL 33771 Wayne DeHaven Phone: 727-209-5778 BIOLOGICAL Valid To: November 30, 2026
Test Method(s) Reference Method(s) Growth Promotion Test BP <Appendix XVI B> EP 2.6.12, 0169 USP <61>, <1117> Identification of Bacteria and Yeast by AccuPRO-ID® and Filamentous Fungi by AccuFUN-ID® NEW-SOP-00117 Identification
Prüfgebiet Prüfgegenstand Produkt(kategorie) Prüfungsart Prüfung Regelwerk Prüfverfahren Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485 : 2021, Abs. 6.4 und Abs. 7.5 Mikrobio
Teknikområde Parameter Metod Mätprincip Provtyp Flex Typ av flex Fält Anmärkning Totalantal mikroorganismer, kvantitativ Ph. Eur. 5.1.3. Efficacy of microbial preservation Läkemedel Ja 2 Nej Medicintekniska produkter Ja 2 Nej SS-EN IS
USP 61> ATP#MB006 <USP 2021> Total Yeast/Mold Count ATP#MB001 <USP 61> ATP#MB006 <USP 2021> Escherichia coli ATP#MB001 <USP 62> ATP#MB006 <USP 2022> Pseudomonas species ATP#MB001 <USP 62> Salmonella species ATP#MB001 <USP 62> ATP#MB
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 SGS NORTH AMERICA, INC. 2421 W. Peoria Avenue, Suite 110 Phoenix, AZ 85029 Tia Walton-Streeter Phone: 972 392 1529 BIOLOGICAL Valid To: February 28, 2027 Certificate N
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 DAANE LABS 4795 Enterprise Ave. Naples, FL 34104 Andrew Daane Phone: 239 227 4735 BIOLOGICAL Valid To: March 31, 2026
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 EUROFINS SF ANALYTICAL – GMP MICROBIOLOGY 215 Witmer Road Horsham, PA 19044 Maureen Dougherty Phone: (267) 282-2100 BIOLOGICAL Valid To: March 31, 2027
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 ADVANCED TESTING LABORATORY 25 Whitney Drive, Suite 110 Milford, OH 45150 Loc Nguyen Phone: 513-489-8447 BIOLOGICAL Valid To: February 28, 2027
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 GARRETT LABORATORIES INC. 408 N. 3rd Street Niles, MI 49120 Robert Garrett Phone: 800 336-3201 BIOLOGICAL Valid To: September 30, 2026