GIBRALTAR LABORATORIES
LIST OF TEST SERVICES

Service

Turn Around Time

Sample Quantity

1.         

1,4-DIOXANE

Varies

Varies

2.         

MYCOPLASMA TEST

28 Days

Varies

3.         

21 CFR SEC 111.65 (C ) (4) CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS; REQUIREMENTS FOR MANUFACTURING

Varies

Varies

4.         

9 CFR 13.28 MYCOPLASMA TEST

7 Days

Varies

5.         

AAMI METHOD 1/ISO 11137 BIOBURDEN (METHOD I, METHOD 2 AND VDMAX)

7 Days

1 Lot of 10 Units

6.         

AAMI METHOD 1/ISO 11137 STERILITY (METHOD I, METHOD 2 AND VDMAX)

14 Days

100 Units

7.         

AAMI ST77 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION

Varies

Varies

8.         

AAMI TIR 12: DESIGNING, TESTING AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR DEVICE MANUFACTURERS

Varies

Varies

9.         

AAMI TIR 30: A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES.

Varies

Varies

10.      

AAMI TIR 33: STERILIZATION OF HEALTH CARE PRODUCTS — RADIATION SUBSTANTIATION OF A SELECTED STERILIATION DOSE — METHOD VDMAX

11.      

AAMI TIR 37: STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – GUIDANCE ON STERILIZATION OF HUMAN TISSUE BASED PRODUCTS

12.      

ACCELERATED AGING

13.      

ACCELERATED AGING/STABILITY TESTING

Varies

14.      

ACID VALUE

Varies

Varies

15.      

ACIDITY

Varies

Varies

16.      

ACNE STUDIES (Propionbactger acnes)

Varies

Varies

17.      

AEROBIC PLATE COUNT (APC)

2-5 Days

100 Units

18.      

AGAR DIFFUSION (BACTERIA)

19.      

AIR SAMPLING (NON-VIABLE)

1 Day

20.      

ANAEROBIC COUNT

 6 Days

21.      

ANSI/AAMI ST72: BACTERIAL ENDOTOXINS TEST METHODOLOGIES, ROUTINE MONITORING, AND ALTERNATIVES TO BATCH TESTING

7 Days 

3-10 Units

22.      

ANSI/AAMI TIR 35: STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS

23.      

ANSI/AAMI/ISO 11737-1: STERILIZATION OF MEDICAL DEVICES MICROBIOLOGICAL METHODS - PART 1: ESTIMATION OF THE POPULATION OF MICROORGANISMS ON PRODUCT

 7 Days 

 10 Units

24.      

ANSI/AAMI/ISO 11737-2: STERILIZATION OF MEDICAL DEVICES MICROBIOLOGICAL METHODS, PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF A STERILIZATION PROCESS

 14 Days 

 10-100 Units

25.      

ANTIBIOTIC ASSAYS

Varies

Varies

26.      

ANTIBIOTIC RESISTANCE SCREENING

27.      

AOAC/ EPA FIFRA GERMICIDAL SPRAY TEST

28.      

AOAC/EPA FIFRA FUNGICIDAL TEST (See additional information)

14 Days

Varies

29.      

AOAC/EPA FIFRA GERMICIDAL SPRAY TEST

7 Days

Varies

30.      

AOAC/EPA FIFRA SPORICIDAL TEST (See additional information)

31.      

AOAC/EPA FIFRA TUBERCULOCIDAL (EPA LOG REDUCTION) (See additional information)

 90 Days

32.      

AOAC/EPA FIFRA USE-DILUTION TEST

7 Days

Varies

33.      

ASTM C110 Standard Test Methods for Physical Testing of Quicklime, Hydrated Lime, and Limestone

Varies

Varies

34.      

ASTM D1193 Standard Specification for Reagent Water

Varies

Varies

35.      

ASTM D1209 Standard Test Method for Color of Clear Liquids (Platinum-Cobalt Scale)

Varies

Varies

36.      

ASTM D1293 Standard Test Methods for pH of Water

Varies

Varies

37.      

ASTM D153 Standard Test Methods for Specific Gravity of Pigments

Varies

Varies

38.      

ASTM D1544 Standard Test Method for Color of Transparent Liquids (Gardner Color Scale)

Varies

Varies

39.      

ASTM D4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method

Varies

Varies

40.      

ASTM D565 Standard Test Method for Carbonizable Substances in White Mineral Oil

Varies

Varies

41.      

ASTM D891 Standard Test Methods for Specific Gravity, Apparent, of Liquid Industrial Chemicals

Varies

Varies

42.      

ASTM D914 Standard Test Methods for Ethylcellulose

Varies

Varies

43.      

ASTM E1054 Standard Test Method for Evaluation of Inactivators of Antimicrobial Agents

 Varies

Varies

44.      

ASTM E1174 Test Method for Evaluation of the Effectiveness of Health Care Personnel Handwash Formulations

Varies

Varies

45.      

ASTM E1766 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

Varies

Varies

46.      

ASTM E1766 Standard Test Method for Determination of Effectiveness of Sterilization Processes for Reusable Medical Devices

Varies

Varies

47.      

ASTM E1837 Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test)

Varies

Varies

48.      

ASTM E2314 Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)

Varies

Varies

49.      

ASTM E2362 Standard Practice for Evaluation of Pre-saturated or Impregnated Towelettes for Hard Surface Disinfection

Varies

Varies

50.      

ASTM E2414 Standard Test Method for Quantitative Sporicidal Three-Step Method (TSM) to Determine Sporicidal Efficacy of Liquids, Liquid Sprays, and Vapor or Gases on Contaminated Carrier Surfaces

Varies

Varies

51.      

ASTM E313 Standard Practice for Calculating Yellowness and Whiteness Indices from Instrumentally Measured Color Coordinates

Varies

Varies

52.      

ASTM E515 Standard Test Method for Leaks Using Bubble Emission Techniques

2-5 Days

Varies

53.      

ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

Varies

Varies

54.      

ASTM F1608 Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

Varies

Varies

55.      

ASTM F1670 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

Varies

Varies

56.      

ASTM F1671 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

Varies

Varies

57.      

ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Varies

Varies

58.      

ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Varies

Varies

59.      

ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

Varies

Varies

60.      

ASTM F316 Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test

Varies

Varies

61.      

ASTM F838 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration

Varies

Varies

62.      

ASTM G21 Standard Practice for Determining Resistance of Synthetic Polymeric Materials to Fungi

Varies

Varies

63.      

AVAILABLE CHLORINE GERMICIDAL EQUIVALENT

 7 Days

64.      

AVIAN INFLUENZA ATTC # VR 797, STRAIN A/MASS 71 (BIRD FLU)

6 Weeks

Varies

65.      

AVIAN INFLUENZA ATTC# VR 798, STRAIN A/WISCONSIN/68 (BIRD FLU)

6 Weeks

Varies

66.      

AVOBENZONE ASSAY

Varies

Varies

67.      

BACILLUS CEREUS COUNT

 3 Days

68.      

BENZOCAINE ASSAY

14 Days

1 Unit

69.      

BICINCHONINIC ACID PROTEIN ASSAY

70.      

BIOBURDEN RECOVERY VALIDATION (BY SPORE INOCULATION)

7 Days

3 Units

71.      

BIOBURDEN TEST

 7 Days

1-10 Units / Lot

72.      

BIOLOGICAL INDICATOR (BI) REDUCED INCUBATION

 7 Days

73.      

BIOLOGICAL INDICATOR TESTING

3-7 Days

Varies

74.      

BIOLOGICAL INDICATOR, SELF CONTAINED TESTED

2-4 Days

Varies

75.      

BRITISH PHARMACOPEIA PURIFIED WATER (TOC, CONDUCTIVITY, NITRATES, HEAVY METALS)

 7 Days

76.      

BRITISH PHARMACOPEIA STERILITY TESTING appendix xvi,a

 14 Days

77.      

BRITISH PHARMACOPOEIA AET appendix xvi,c

78.      

BRITISH PHARMACOPOEIA Endotoxin appendix xvi,c

2 Days

79.      

BUBBLE POINT INTEGRITY TESTING

7 Days

80.      

BURST TEST

2-5 Days

Varies

81.      

BUTYLMETHOXYDIBENZOMETHANE

82.      

CAFFEINE ASSAY

Varies

Varies

83.      

CALORIES

1 Day

84.      

CARBOHYDRATE (TOTAL)

85.      

CARBON DIOXIDE

86.      

CFR 9 113.46 DETECTION OF CYTOPATHOGENIC AND/OR HEMADSORBING AGENTS

87.      

CFR 9 113.47 DETECTION OF EXTRANEOUS VIRUSES BY THE FLUORESCENT ANTIBODY TECHNIQUE.

88.      

CFR 9 113.53 REQUIREMENTS FOR INGREDIENTS OF ANIMAL ORIGIN USED FOR PRODUCTION OF BIOLOGICS

89.      

CFR MYCOPLASMA

28 Days

90.      

CFR STERILITY TESTING

14 Days

91.      

CHLORIDE

92.      

CHROMATOGRAPHIC PURITY

Varies

Varies

93.      

CLEANING VALIDATION

Varies

Varies

94.      

COAGULATION

1 Day

Varies

95.      

COLIFORM COUNT (TOTAL)

2-3 Days

96.      

COLOR

 1 Day

97.      

COMPLEMENT ACTIVATION

14 Days

98.      

COMPRESSED AIR SAMPLING

1 Day

99.      

CONDUCTIVITY

1 Day

100.   

CONSULTATION

Varies

 Varies

101.   

CONTAINER INTEGRITY CHALLENGE TEST

7 Days

102.   

COSMETIC MICROBIOLOGY PRESERVATIVE EFFECTIVENESS BY USP OR CTFA

14-28 Days

50-100 grams

103.   

COSMETIC MICROBIOLOGY TOTAL COUNT, TOTAL GRAM NEGATIVE RODS, TOTAL YEAST MOLDS, PRESENCE ABSENCE PATHOGENS

5 Days

10 grams

104.   

CREEP TEST

Varies

Varies

105.   

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS; REQUIREMENTS FOR MANUFACTURING 21 CFR SEC 111.65 (C ) (4)

Varies

Varies

106.   

CYTOTOXICITY TEST, BICINCHONINIC ACID ASSAY

7 Days

107.   

DEXASAMETHASONE ACETATE ASSAY

14 Days

1 Unit

108.   

DIMETHICONE ASSAY

Varies

Varies

109.   

DIOXANE-1,4

Varies

Varies

110.   

DISPERSABILITY IN WATER

7 Days

111.   

DISSOLUTION

14 Days

Varies

112.   

DNASE ACTIVITY

Varies

Varies

113.   

DRAEGER DIRECTIONAL

Varies

Varies

114.   

DRYING OF INSTRUMENTS AFTER STEAM STERILIZATION

Varies

Varies

115.   

EDTA CONCENTRATION DETERMINATION

7 Days

116.   

ELASTIN ASSAY (SOLUBLE INSOLUBLE AND TOTAL ELASTINS)

1 Week

Varies

117.   

ELEMENTAL ANALYSIS (C, N, H, O, S)

Varies

Varies

118.   

ELUTION CYTOTOXICITY

Varies

Varies

119.   

EN 1040

Varies

Varies

120.   

ENVIRONMENTAL MONITORING (AIRSTRIPS)

3-7 Days

Varies

121.   

ENVIRONMENTAL MONITORING (CONTACT PLATES)

3-7 Days

Varies

122.   

ENVIRONMENTAL MONITORING (NON-VIABLE)

1 Day

Varies

123.   

ENVIRONMENTAL MONITORING (SAMPLING)

1 Day

Varies

124.   

ENVIRONMENTAL MONITORING (SETTLING PLATES)

3-7 Days

Varies

125.   

ENVIRONMENTAL MONITORING (TRAINING)

1 Day

126.   

EPA FOOD CONTACT SANITIZER SCREENING TEST

 5 Days

1 Lot

127.   

EPA FOOD CONTACT SANITIZER TEST

 5-7 Days

3 Lots

128.   

EPA HARD SURFACE MILDEW FUNGISTATIC TEST

14 Days

2 Lots, 3 Concentrations

129.   

EPA RED GLP EFFICACY

Varies

Varies

130.   

EPA RED GLP PRODUCT CHEMISTRY

Varies

Varies

131.   

EPA SUBDIVISION D:PRODUCT CHEMISTRY

3-4 Weeks

Varies

132.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: DISINFECTANTS (GENERAL OR BROAD SPECTRUM EFFICACY)

133.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: DISINFECTANTS (HOSPITAL OR MEDICAL ENVIRONMENT EFFICACY)

134.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: DISINFECTANTS (LIMITED EFFICACY)

135.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: FOOD CONTACT SANITIZERS (FOR HALIDE AND OTHER CHEMICAL PRODUCTS)

136.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: FUNGICIDES (PATHOGENIC FUNGI)

137.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: NON-FOOD CONTACT SANITIZERS

138.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: SPORICIDAL CLAIMS

139.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: SUPPLEMENTAL ORGANISMS

140.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: TUBERCULOCIDES

141.   

EPA SUBDIVISION G – PRODUCT PERFORMANCE: VIRUCIDES

142.   

ETHYLENE OXIDE RESIDUAL ANALYSIS

21 Days

143.   

EUROPEAN PHARMACOPEIA PURIFIED WATER TOC <2.2.44> CONDUCTIVITY

40 mL/100 mL

144.   

EUROPEAN PHARMACOPEIA STERILITY TEST <2.6.1>

 14 Days

145.   

EUROPEAN PHARMACOPOEIA <5.13> AET

 35 Days

146.   

EUROPEAN PHARMACOPOEIA ENDOTOXIN TEST <2.6.14>

 1-3 Days

147.   

EUROPEAN PHARMACOPOEIA MICROBIAL LIMITS AND PREPARATORY TEST <2.6.12>, <2.6.13>

148.   

EUROPEAN PHARMACOPOEIA WET CHEMISTRY TESTS

 2 Days

149.   

EXPIRATION DATING

150.   

FAT (SATURATED)

151.   

FAT (TOTAL)

152.   

FIBER (TOTAL DIETARY)

153.   

FIBER (TOTAL SOLUBLE)

154.   

FLOURIDE ANALYSIS BY ION SELECTIVE ELECTRODES [TOTAL, AVAILABLE AND FREE FLOURIDE]

Varies

Varies

155.   

FOOD CHEMISTRY

 21 Days

156.   

FORCE DEGRADATION (STRESS testing)

Varies

Varies

157.   

FORMALDEHYDE

Varies

Varies

158.   

FTIR ANALYSIS

 7 Days

159.   

GC CHEMISTRY

 21 Days

160.   

GLUTARALDEHYDE

Varies

Varies

161.   

GOLDEN THREAD™

Digital Trending, Alert/Action Control Limits

162.   

GROWTH PROMOTION

3-7 Days

163.   

HAND SANITIZERS

164.   

HEAT PENETRATION CASE DEVELOPMENT F0 STUDIES

Varies

Varies

165.   

HPLC CHEMISTRY POTENCY/IDENTITY

166.   

HUMAN PATCH-20 SUBJECTS

3 Days

20 Square Inches

167.   

HUMAN PATCH-5 SUBJECTS

3 Days

5 Square Inches

168.   

ICH STORAGE

 Varies

169.   

IN VITRO TOXICOLOGY APPT, THROBORESISTANCE

170.   

IN VITRO TOXICOLOGY USP <87> CYOTOXICITY

171.   

INOCULATED PRODUCT PREPARATION

172.   

INTERFERON ASSAY

14 Days

Varies

173.   

INULIN CONTENT

174.   

IODINE VALUE

Varies

Varies

175.   

ISO 10993-5: BIOLOGICAL EVALUATION OF MEDICAL DEVICES – PART 5: TESTS FOR IN VITRO CYTOTOXICITY BIOCOMPATIBITY

176.   

ISO 10993-7: BIOLOGICAL EVALUATION OF MEDICAL DEVICES

177.   

ISO 11137 STERILIZATION

178.   

ISO 11607 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

Varies

Varies

179.   

ISO 11737-2:1998 STERILIZATION OF MEDICAL DEVICES-MICROBIOLOGICAL METHODS

7 Days

Varies

180.   

ISO 14644-1 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS

Varies

Varies

181.   

ISO 4730 TEA TREE OIL

Varies

Varies

182.   

ISO 8871-1: 2003 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE -- PART 2: IDENTIFICATION AND CHARACTERIZATION

183.   

ISO 8871-1-4 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE

Varies

Varies

184.   

ISO CYTOTOXICITY

2 Days

Varies

185.   

JAPANESE PHARMACOPEIA PURIFIED WATER

 5 Days

186.   

JAPANESE PHARMACOPEIA STERILITY TEST SECTION 45

 14 Days

187.   

JAPANESE PHARMACOPOEIA AET

188.   

JAPANESE PHARMACOPOEIA ENDOTOXIN TEST SECTION 6

189.   

KARL FISHER

 1 Day

190.   

LAL GEL-CLOT INHIBITION/ENHANCEMENT VALIDATION

 1 Day

191.   

LAL GEL-CLOT TEST

 3 Days

3-10 Units

192.   

LAL KINETIC CHROMOGENIC INHIBITION/ENHANCEMENT VALIDATION

 1 Day

193.   

LAL KINETIC CHROMOGENIC TEST

 3 Days

3-10 Units

194.   

LEAK TEST

Varies

Varies

195.   

LIDOCAINE ASSAY

Varies

Varies

196.   

LINALOOL ASSAY

Varies

Varies

197.   

LOSS ON DRYING

 1 Day

198.   

MEDIA FILL 3000-5000 14 DAY TEST

 14 Days

199.   

MEDIA FILL STERILITY TEST

 21 Days

200.   

MELTING RANGE

1 Day

201.   

MEMBRANE FILTRATION FOR STERILITY USP <71>, EP

7 Days

202.   

MENTHOL ASSAY

14 Days

1 Unit

203.   

METHOD DEVELOPMENT

Varies