GIBRALTAR LABORATORIES
MICRO TEST SERVICES

1.         

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

2.         

9 CFR 13.28 MYCOPLASMA TEST

7 Days

Varies

3.         

ACNE STUDIES (Propionbactger acnes)

Varies

Varies

4.         

AEROBIC PLATE COUNT (APC)

2-5 Days

100 Units

5.         

AGAR DIFFUSION (BACTERIA)

6.         

AIR SAMPLING (NON-VIABLE)

1 Day

7.         

ANAEROBIC COUNT

 6 Days

8.         

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

7 Days 

3-10 Units

9.         

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

10.      

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

11.      

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

12.      

ANTIBIOTIC ASSAYS

Varies

Varies

13.      

ANTIBIOTIC RESISTANCE SCREENING

14.      

AOAC/ EPA FIFRA GERMICIDAL SPRAY TEST

15.      

AOAC/EPA FIFRA FUNGICIDAL TEST (See additional information)

14 Days

Varies

16.      

AOAC/EPA FIFRA GERMICIDAL SPRAY TEST

7 Days

Varies

17.      

AOAC/EPA FIFRA SPORICIDAL TEST (See additional information)

18.      

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

 90 Days

19.      

AOAC/EPA FIFRA USE-DILUTION TEST

7 Days

Varies

20.      

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

Varies

Varies

21.      

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

 Varies

Varies

22.      

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

Varies

Varies

23.      

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

Varies

Varies

24.      

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

Varies

Varies

25.      

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

Varies

Varies

26.      

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

27.      

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

Varies

Varies

28.      

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

29.      

ASTM E515 Standard Test Method for Leaks Using Bubble Emission Techniques

2-5 Days

Varies

30.      

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

Varies

Varies

31.      

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

Varies

Varies

32.      

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

Varies

Varies

33.      

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

34.      

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

Varies

Varies

35.      

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

Varies

Varies

36.      

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

Varies

Varies

37.      

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

Varies

Varies

38.      

AVAILABLE CHLORINE GERMICIDAL EQUIVALENT

 7 Days

39.      

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

6 Weeks

Varies

40.      

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

6 Weeks

Varies

41.      

BACILLUS CEREUS COUNT

 3 Days

42.      

BICINCHONINIC ACID PROTEIN ASSAY

43.      

BIOBURDEN RECOVERY VALIDATION (BY SPORE INOCULATION)

7 Days

3 Units

44.      

BIOBURDEN TEST

 7 Days

1-10 Units / Lot

45.      

BIOLOGICAL INDICATOR (BI) REDUCED INCUBATION

 7 Days

46.      

BIOLOGICAL INDICATOR TESTING

3-7 Days

Varies

47.      

BIOLOGICAL INDICATOR, SELF CONTAINED TESTED

2-4 Days

Varies

48.      

BRITISH PHARMACOPEIA STERILITY TESTING appendix xvi,a

 14 Days

49.      

BRITISH PHARMACOPOEIA AET appendix xvi,c

50.      

BRITISH PHARMACOPOEIA Endotoxin appendix xvi,c

2 Days

51.      

BUBBLE POINT INTEGRITY TESTING

7 Days

52.      

BURST TEST

2-5 Days

Varies

53.      

CARBON DIOXIDE

54.      

CFR 9 113.46 DETECTION OF CYTOPATHOGENIC AND/OR HEMADSORBING AGENTS

55.      

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

56.      

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

57.      

CFR MYCOPLASMA

28 Days

58.      

CFR STERILITY TESTING

14 Days

59.      

CLEANING VALIDATION

Varies

Varies

60.      

COAGULATION

1 Day

Varies

61.      

COLIFORM COUNT (TOTAL)

2-3 Days

62.      

COMPLEMENT ACTIVATION

14 Days

63.      

COMPRESSED AIR SAMPLING

1 Day

64.      

CONSULTATION

Varies

 Varies

65.      

CONTAINER INTEGRITY CHALLENGE TEST

7 Days

66.      

COSMETIC MICROBIOLOGY PRESERVATIVE EFFECTIVENESS BY USP OR CTFA

14-28 Days

50-100 grams

67.      

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

5 Days

10 grams

68.      

CREEP TEST

Varies

Varies

69.      

CYTOTOXICITY TEST, BICINCHONINIC ACID ASSAY

7 Days

70.      

DNASE ACTIVITY

Varies

Varies

71.      

DRAEGER DIRECTIONAL

Varies

Varies

72.      

DRYING OF INSTRUMENTS AFTER STEAM STERILIZATION

Varies

Varies

73.      

EDTA CONCENTRATION DETERMINATION

7 Days

74.      

ELUTION CYTOTOXICITY

Varies

Varies

75.      

EN 1040

Varies

Varies

76.      

ENVIRONMENTAL MONITORING (AIRSTRIPS)

3-7 Days

Varies

77.      

ENVIRONMENTAL MONITORING (CONTACT PLATES)

3-7 Days

Varies

78.      

ENVIRONMENTAL MONITORING (NON-VIABLE)

1 Day

Varies

79.      

ENVIRONMENTAL MONITORING (SAMPLING)

1 Day

Varies

80.      

ENVIRONMENTAL MONITORING (SETTLING PLATES)

3-7 Days

Varies

81.      

ENVIRONMENTAL MONITORING (TRAINING)

1 Day

82.      

EPA FOOD CONTACT SANITIZER SCREENING TEST

 5 Days

1 Lot

83.      

EPA FOOD CONTACT SANITIZER TEST

 5-7 Days

3 Lots

84.      

EPA HARD SURFACE MILDEW FUNGISTATIC TEST

14 Days

2 Lots, 3 Concentrations

85.      

EPA RED GLP EFFICACY

Varies

Varies

86.      

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

87.      

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

88.      

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

89.      

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

90.      

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

91.      

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

92.      

EPA SUBDIVISION G – PRODUCT PERFORMANCE: SPORICIDAL CLAIMS

93.      

EPA SUBDIVISION G – PRODUCT PERFORMANCE: SUPPLEMENTAL ORGANISMS

94.      

EPA SUBDIVISION G – PRODUCT PERFORMANCE: TUBERCULOCIDES

95.      

EPA SUBDIVISION G – PRODUCT PERFORMANCE: VIRUCIDES

96.      

EUROPEAN PHARMACOPEIA STERILITY TEST <2.6.1>

 14 Days

97.      

EUROPEAN PHARMACOPOEIA <5.13> AET

 35 Days

98.      

EUROPEAN PHARMACOPOEIA ENDOTOXIN TEST <2.6.14>

 1-3 Days

99.      

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

100.   

EXPIRATION DATING

101.   

FORCE DEGRADATION (STRESS testing)

Varies

Varies

102.   

GOLDEN THREAD™

Digital Trending, Alert/Action Control Limits

103.   

GROWTH PROMOTION

3-7 Days

104.   

HAND SANITIZERS

105.   

HEAT PENETRATION CASE DEVELOPMENT F0 STUDIES

Varies

Varies

106.   

HUMAN PATCH-20 SUBJECTS

3 Days

20 Square Inches

107.   

HUMAN PATCH-5 SUBJECTS

3 Days

5 Square Inches

108.   

IN VITRO TOXICOLOGY APPT, THROBORESISTANCE

109.   

IN VITRO TOXICOLOGY USP <87> CYOTOXICITY

110.   

INOCULATED PRODUCT PREPARATION

111.   

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

112.   

ISO 10993-7: BIOLOGICAL EVALUATION OF MEDICAL DEVICES

113.   

ISO 11137 STERILIZATION

114.   

ISO 11607 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

Varies

Varies

115.   

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

7 Days

Varies

116.   

ISO 14644-1 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS

Varies

Varies

117.   

ISO 4730 TEA TREE OIL

Varies

Varies

118.   

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

Varies

Varies

119.   

ISO CYTOTOXICITY

2 Days

Varies

120.   

JAPANESE PHARMACOPEIA PURIFIED WATER

 5 Days

121.   

JAPANESE PHARMACOPEIA STERILITY TEST SECTION 45

 14 Days

122.   

JAPANESE PHARMACOPOEIA AET

123.   

JAPANESE PHARMACOPOEIA ENDOTOXIN TEST SECTION 6

124.   

LAL GEL-CLOT INHIBITION/ENHANCEMENT VALIDATION

 1 Day

125.   

LAL GEL-CLOT TEST

 3 Days

3-10 Units

126.   

LAL KINETIC CHROMOGENIC INHIBITION/ENHANCEMENT VALIDATION

 1 Day

127.   

LAL KINETIC CHROMOGENIC TEST

 3 Days

3-10 Units

128.   

LEAK TEST

Varies

Varies

129.   

MEDIA FILL 3000-5000 14 DAY TEST

 14 Days

130.   

MEDIA FILL STERILITY TEST

 21 Days

131.   

MEMBRANE FILTRATION FOR STERILITY USP <71>, EP

7 Days

132.   

METHOD DEVELOPMENT

Varies

Varies

133.   

METHOD TRANSFER

Varies

Varies

134.   

METHOD VALIDATION

Varies

Varies

135.   

MIC/MBC

5-7 Days

136.   

MICROBIAL CHARACTERIZATION (GRAM STAINS)

 2 Days

137.   

MICROBIAL CONTENT TEST

 7 Days

138.   

MICROBIAL IDENTIFICATIONS (BACTERIAL)

3-4 Days

139.   

MICROBIAL IDENTIFICATIONS (BIOCHEMICAL TESTS)

 3-4 Days

140.   

MICROBIAL IDENTIFICATIONS (MOLD)

14-21 Days

141.   

MICROBIAL IDENTIFICATIONS (YEAST)

3-4 Days

142.   

MICROBIAL INGRESS POSITIVE PRESSURE TEST

Varies

Varies

143.   

MICROBIAL INGRESS VIA VACUUM PULSE TEST

Varies

Varies

144.   

MICROBIAL KILLING TIME

 7 Days

145.   

MOLD IDENTIFICATION

2 Weeks

1 Sample

146.   

MYCOPLASMA BY PCR

1-7 Days

Varies

147.   

MYCOPLASMA TEST

28 Days

Varies

148.   

MYCOPLASMA TEST 21 CFR 610.30

28 Days

Varies

149.   

MYCOPLASMA TEST 9 CFR 13.28

7 Days

Varies

150.   

NITROGEN

 14-21 Days

151.   

NON-VIABLE PARTICULATE COUNT (GAS)

 1 Day

152.   

NOROVIRUS (FELINE CALICIVIRUS)

153.   

PACKAGE INTEGRITY TEST (METHYLENE BLUE DYE)

24 Hours

5 Samples

154.   

PATHOGEN DETECTION

Varies

Varies

155.   

PERSONNEL MONITORING

 Varies

156.   

PROCESS VALIDATION

Varies

Varies

157.   

PYRONEMA

 28 Days

158.   

QUANTITATIVE CARRIER TEST

48 Hours

Varies

159.   

REVERSE MUTATION ASSAY

 14 Days

160.   

RNASE ACTIVITY

Varies

Varies

161.   

RUSH/STAT CHARGE

 Varies

Varies

162.   

SALMONELLA COUNT

 3 Days

163.   

SELF CONTAINED BIOLOGICAL INDICATOR TESTING

2-14 Days

Varies

164.   

SOP PREPARATION

 Varies

N/A

165.   

STAPHYLOCOCCUS AUREUS COUNT

 3 Days

166.   

STEAM STERILIZATION

Varies

Varies

167.   

STERILITY TEST BY MEMBRANE FILTRATION

 14 Days

168.   

STERILITY TESTING

 14 Days

169.   

TB LOG REDUCTION

170.   

THERMAL MAPPING AND PERFORMANCE QUALIFICATION OF AUTOCLAVES, OVENS, INCUBATORS AND REFRIGERATORS

Varies

Varies

171.   

THERMAL MAPPING OF INCUBATORS, REFRIGERATORS, AUTOCLAVES, OVENS

Varies

Varies

172.   

THERMOPHILIC PLATE COUNT

 7 Days

173.