MicroMed Laboratories- Microbiology Testing, CER Monitoring, and Consulting

LABORATORY TESTING
	Bioburden Extraction Efficiency
	Bioburden Testing
	Water Testing – Bioburdens/Coliforms
	USP 61 Microbial Enumeration
	USP 61/.62 Method Suitability
	Bacteriostasis/Fungistasis
	Microbial Identification
	Sterility Testing
	Sterility Validation
	VDmax Validation
	Dose Audits
	Cleaning and Disinfection Validation
	Autoclave Cycle Qualification
	Autoclave Cycle Validation
	Endotoxin/Pyrogen (LAL) Validation
	Endotoxin/Pyrogen (LAL) Testing
	Cytotoxicity Testing
	Biological Indicator Population Verification
	DNase/RNase Testing
	Protease Testing
	Total Organic Carbon (TOC) Testing
	HPLC Testing
	Shelf Life Studies and Package Integrity Testing
	Environmental Chamber/Oven IQ/OQ/PQ

MicroMed offers a fully equipped laboratory and a wide spectrum of microbiology tests. Our laboratory is in compliance with the ISO 13485 quality system, ISO 9001:2008 certified and complies with U.S. GMP and Quality System Regulations. Our experts understand your needs for quality testing and timely, accurate results.

Laboratory Testing Programs

Bioburden Extraction Efficiency - ISO 11737-1, USP <1231>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
BI-006	Bioburden Extraction Efficiency-Exhaustive Rinse	Sampling plan based on intended use.	9 days	7 days

Bioburden Testing - ISO 11737-1, USP <1231>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
BI-001	Aerobic Bacteria	Per related validation documenting ISO 11137 n=10 or based on client sampling plan	9 days	7 days
BI-002	Aerobic & Fungi		9 days	7 days
BI-003	Aerobic & Spore		9 days	7 days
BI-004	Aerobic, Spores & Fungi		9 days	7 days
BI-005	Bioburden Validation-Spore Inoculation	Sampling plan based on intended use.	9 days	7 days
BI-006	Bioburden Extraction Efficiency-Exhaustive Rinse		9 days	7 days
BI-007	Bioburden-Direct Filtration (100ml sample required for water)		9 days	7 days

Water Testing-Bioburdens/Coliforms - ISO 11737-1, USP <1231>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
BI-007	Direct Filtration – total heterotrophic count	Inquire	11 days	9 days
BI-009	Direct Filtration – total coliform count A. Total count B. If positive – Conformity test	Inquire	9 days + 4 days for confirmation	7 days + 4 days for confirmation

USP 61 Microbial Enumeration - USP <61>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
P61-001	Aerobic & Fungi-Microbial Enumeration	Sampling plan based on intended use.	9 days	7 days

USP 61/.62 Method Suitability - USP <61>, USP <62>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
P612-001	Validation for Microbial enumeration	Sampling plan based on intended use. (non sterile product is being submitted)	9 days	7 days

Microbial Identification

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
ID-002	Bacterial Identification, to species	We recommend some characterization of Environmental Monitoring and Bioburden data on a regular basis per guidance documentation	5-21 days	3-14 days
ID-003	Fungi, to genus (mold and yeast)		5-21 days	3-14 days
ID-004	Gram Stain		2-3 days	1 day

Bacteriostasis/Fungistasis - USP <71>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
ST-001	Bacteriostasis/Fungistasis, USP Method	Per USP or ISO depending on lot size Chart Based on chamber size per ISO 11135 Chart	5-7 days	3-5 days

Sterility Testing - USP <71>

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
ST-001	Bacteriostasis/Fungistasis, USP Method	Per USP or ISO depending on lot size Chart Based on chamber size per ISO 11135 Chart	5 days	3 days
ST-002	Direct Transfer Method-per device or solution		16-18 days	14-16 days
ST-003	Direct Transfer Method-Spore Strips		9-11 days	7-9 days
ST-004	Growth Promotion Test-of Cultured Media		5-7 days	3-5 days
ST-005	Autoclave Cycle		9-11 days	7-9 days
ST-006	Direct Transfer-Biological product		9-11 days	7-9 days

VDmax Validation - ISO11137-2

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
VD-015	Method 1 Validation	3 lots of 20 units plus 3 units for bioburden validation and 3 for Bacti Fungi Statis testing	35 days	30 days
VD-025	Method 2 Validation		35 days	30 days

Sterilization Validation - ISO 11137

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
M1-015	Sterilization Validation	3 units for Bacti/Fungistasis. 10 units for sterility testing.	16-18 days	14-16 days

Dose Audits - ISO 11137

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
DA-001	Dose Audit Method 1	10 units for bioburden and 10 units for Sterility	16-18 days	14-16 days
DA-002	Dose Audit Method 2	10 units for bioburden and 10 units for Sterility	16-18 days	14-16 days

Cleaning and Disinfection Validation – reusable device – AAMI, TIR 12, AAMI, TIR 30

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
RD-001	Cleaning and Disinfection Validation -reusable device	Inquire	30 days	14 days

Autoclave Cycle Validation - HTM 2010, EN 285, EN17765, PDA Monograph and ISO standards

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
CV-001	Autoclave Cycle Validation	Inquire	3-4 weeks	2 weeks

Autoclave Cycle Qualifications - ANSI/AAMI/ISO 11134-1993

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
CQ-001	Autoclave Cycle Qualification	Inquire	3-4 weeks	2 weeks

Endotoxin/Pyrogen (LAL) Validation - FDA Guideline, USP <85>, AAMI ST72:2002

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
PY-005	LAL Product Validation-Inhibition & Enhancement (3 lots) (required for first time testing)	Medical Device: 10 units per each lot pooled- 30 units=3 groups of 10	2-3 days	1 day

Endotoxin/Pyrogen (LAL) Testing - FDA Guideline, USP <85>, AAMI ST72:2002

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
PY-001	Pyrogen (LAL) Kinetic Turbidimetric	For medical Devices: Lot size 1-30=2 30-100=3 Over 100=3% Max =10	2-3 days	1 day
PY-002	Pyrogen (LAL) Chromogenic		2-3 days	1 day
PY-003	Water Pyrogenicity Testing		2-3 days	1 day
PY-004	Endotoxin spiked vials or components	Medical Device: 10 units per each lot pooled- 30 units=3 groups of 10	2-3 days	1 day
PY-005	LAL Product Validation-Inhibition & Enhancement (3 lots) (required for first time testing)		2-3 days	1 day

Cytotoxicity Testing - USP <87>, ISO 10993-5

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
CY-002	Cytotoxicity Testing-MEM Elution, USP (48 hours)	0.6 grams	5-7 days	3 days
CY-004	Cytotoxicity Testing-MEM Elution, ISO (48 hours)	1.8 grams	5-7 days	3 days
CY-005	Micro-Cytotoxicity Testing-MEM Elution, USP This test is designed for products that are lightweight and expensive. We only require 0.2 grams of material to complete this test.	0.2 grams	5-7 days	3 days
CY-006	Micro-Cytotoxicity Testing-ISO	0.2 grams	5-7 days	3 days
CY-007	Agar Overlay	>100mm²	5-7 days	3 days
CY-008	Direct Contact	>100mm²	5-7 days	3 days
CY-010	MTT Quantitative Cytotoxicity Testing-ISO-6 replicates	0.2 grams	5-7 days	3 days

Biological Indicator Population Verification - USP <55>, ISO 11138-1

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
BP-001	USP	3 strips	3-4 days	2 days
BP-003	Dual Species, USP	3 strips	3-4 days	2 days

DNase/RNase Testing

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
DR-001	DNase/RNase testing	We Recommend: Lot size 1-30=2 30-100=3 Over 100=3% Max =10	7-14 days	2 days

Protease Testing

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
PT-001	Protease testing	We Recommend: Lot size 1-30=2 30-100=3 Over 100=3% Max =10	7-14 days	2 days

TOC - Total Organic Carbon Testing

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
TOC-001	Total Organic Carbon testing (TOC)	40mL in Carbon Free Vial

HPLC – High Performance Liquid Chromatography Testing

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
HPLC-001	High Performance Liquid Chromatography	10uL

Shelf Life Studies and Package Integrity Testing - ISO 11607, ASTM F1929, ASTM 1140

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
PA-001	Dye Penetration	Based on clients statistics, supply plan/confidence reliability	2-3 days	1 day
PA-002	Burst Test		2-3 days	1 day
PA-003	Burst & Creep Test		2-3 days	1 day
PA-004	Accelerated or Real Time Aging		Please call	Please call
PA-005	Creep Test		2-3 days	1 day
PA-006	Bubble Emission		2-3 days	1 day

Environmental Chamber/Oven IQ/OQ/PQ

Test Code	Test Description	Minimum Sample Requirements	Turnaround time	STAT Testing
EQ-001	Environmental Chamber/Oven Qualification	Inquire	3-4 weeks	2 weeks

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