Information in this document is subject to change without notice. While the information contained herein is believed to be accurate and reliable, BioVigilant Systems, Inc., assumes no responsibility for errors or omissions.
IMD®, IMD-A®, PHARMAMASTER®, BIOVIGILANT®, the BioVigilant logo, and the term Instantaneous Microbial Detection are the trademarks or registered trademarks of BioVigilant Systems, Inc. in the United States and/or other countries. Other names or brands may be the property of others.
Introduction This fact sheet provides a summary of test parameters and results for BioVigilant’s IMD-A 300 and IMD-A 350 systems based on USP <1223> and EP 5.1.6 validation guidelines. The IMD-A series of systems is designed to continuously monitor air and instantaneously detect the presence of both single and agglomerated microbes in real time. Testing was performed to demonstrate that the IMD-A systems are equivalent to, if not better than, the compendial microbiological method as per USP <1223> and EP 5.1.6 guidelines. Comparison of the IMD-A systems to the compendial method was gauged through the side-by-side testing of four IMD-A systems, two of each model, and three air samplers common to the pharmaceutical manufacturing environment: the SAS Super 100, MAS 100NT, and SMA. In order to stringently assess all systems, a highly homogenous, state-of-the-art aerosol test chamber was employed in order to ensure that these systems were sampling the same aerosol environment concurrently throughout the extensive test trials. BioVigilant has maintained close communications with the FDA regarding the test plan, statistics utilized, and the subsequent results obtained, now summarized in this fact sheet.
Background In the United States and Europe respectively, the USP <1223> Validation of Alternative Microbiological Methods1 standard, and EP 5.1.6 Alternative methods for control of microbiological quality2 standard guide the validation or implementation of alternative microbiological methods such as BioVigilant’s IMD-A systems. Results from testing to these standards are filed as part of BioVigilant’s Drug Master File (DMF) submissions to the U.S. FDA, which supplement the testing drug makers may perform to validate IMD-A systems for use in their manufacturing areas.
1 General Information Chapter <1223> Validation of Alternative Microbiological Methods. United States Pharmacopeia 33 – National Formulary 28: 2010.
2 Chapter 5.1.6 Alternative methods for control of microbiological quality. European Pharmacopoeia Sixth Edition, Supplement 6.5: 2009.
BioVigilant Tests per USP <1223> / EP 5.1.6
IMD‐A User Tests
Accuracy
Precision
Linearity
Limit of Detection
Limit of Quantification
Ruggedness
Robustness
Range
Specificity
• Follow FDA’s PAT Guidance
• Communicate test plan to FDA and share results
• IQ/OQ/PQ
• Side-by-side testing of the IMD-A system with conventional methods
In addition to the USP <1223> and EP 5.1.6 test results, BioVigilant’s DMF submissions contain information that the FDA can review to approve the use of the rapid microbiological method enabled by BioVigilant’s systems for environmental monitoring in the manufacturing, processing, packaging or storage of drug products. Drug makers reference these filings for FDA submission applications.
DMF Contents
• USP <1223> test information and results
• Environmental & other performance tests
• Published information on comparative traditional methods
• IMD-A model overview including
Technology
Functionality
Calibration
Intended use
Components
• BioVigilant’s IQ/OQ/PQ
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12 replicates tested at each of five concentrations, for all microbes
Facility Yamatake g-Lab, Fujisawa, Japan facility
Test Apparatus 2.9m3 chamber specifically designed for aerosol studies
Salter Laboratories nebulizer
Kanomax 3900 particle counter
Systems Compared
IMD-A 300 system (2 each) IMD-A 350 system (2 each) SAS Super 100 instrument MAS 100NT instrument SMA instrument
Auxiliary Test Site Robustness and Specificity/2 tests were performed at BioVigilant
Test Microbes Five indicator microbes, those common to the pharmaceutical manufacturing environment, were chosen including gram negative and gram positive, vegetative bacteria, and spore-state bacteria, as noted earlier.
Test Facility Biological challenge testing was performed at the Yamatake g-Lab facility in Fujisawa, Japan. The general laboratory area provides a Grade B/ISO 7 environment with the capabilities in place to handle the aerosol testing of BSL-2 organisms. Laboratory personnel have a broad range of experience including microbiology, biochemistry, and industrial hygiene, and specific expertise in fundamental research on bacterial culturability and viability associated with biological aerosol testing.3
3 Hasegawa, N. et al., A study of bacterial culturability during bioaerosol challenge test using a test chamber, Journal of Aerosol Science, 42, 6, 397-407 (2011).
Test Apparatus and Instruments Aerosol Test Chamber All USP <1223> and EP 5.1.6 biological challenge testing was performed in a purpose-built, state-of-the-art aerosol test chamber located in the Yamatake g-Lab facility (Figure 1). The development and engineering of this chamber was based on broad aerosol testing experience and knowledge BioVigilant has accumulated from extensive testing performed in previous years at Dugway Proving Ground, Eglin Air Force Base, Nelson Laboratories, AlburtyLab, Swedish Royal Institute of Technology, and the Kitasato Institute, among others.
The chamber contains a re-circulating HEPA filter with the ability to operate at 10m3 per minute, which is equivalent to roughly three chamber air changes per minute. Sampling instruments are located outside of the chamber, providing the ability to change out media plates and perform maintenance without compromising the test environment within the chamber. The chamber floor contains five ports for inlet sampling tubes of instrumentation (reference particle counters, IMD-A systems), and four ports are located on the chamber sidewall with automated sanitary valves for air sampler interfacing. Furthermore, various sensors monitor chamber conditions and equipment including temperature (22±0.5°C), humidity (50±5%RH), and barometric pressure (<10Pa differential).
Figure 1: Aerosol test chamber in the Yamatake g-Lab facility
Nebulizer A Salter Laboratories 8900-series nebulizer was located inside the test chamber and utilized to disseminate all bacterial suspensions during testing.
Particle Counter An ISO-21501-4-compliant Kanomax 3900 particle counter was used as a reference instrument for microbial aerosol concentrations and to establish background particle count levels during testing.
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Air Samplers (Compendial Method) Three air samplers representing the traditional air sampling method were utilized during testing: the SAS Super 100, MAS 100NT, and SMA. These air samplers were chosen due to their prevalence in pharmaceutical manufacturing environments.
IMD-A 300 and IMD-A 350 (Alternative Microbiological Method) Testing was completed with two of each IMD-A model: IMD-A 300 and IMD-A 350. The IMD-A 300 operates at 1.15 LPM, while the IMD-A 350 operates at 28.3 LPM. Both systems have a particle size detection range from 0.5 µm to ≥ 10 µm, and operate based on a Mie scatter detection method for particle sizing and enumeration, and intrinsic fluorescence detection for biologic classification.
Test Chamber Characterization Significant testing was performed to characterize the aerosol test chamber and its performance for use in validation testing. It has been found that monodisperse bacteria are capable of survival in air, as determined through testing and detection by both air samplers and IMD-A systems; therefore, it was desirable to challenge and confirm the IMD-A systems’ performance when exposed to monodisperse organisms, as these microbes of are the most challenging to detect. Agglomerated microbes are often easier to detect due to their larger size and corresponding higher level of fluorescence. Consequently, testing to ensure the cleanliness and homogeneity of the chamber down to at least a 0.5 micron particle size was performed to ensure an adequate testing environment. These tests included hydrogen leak testing, repeatability testing, chamber uniformity testing, cleanliness testing, and laser-particle visualization of the chamber's aerosol dynamics. Six mixing fans, strategically placed within the chamber, achieved a homogenous aerosol distribution.
Hydrogen Leak Test Molecular hydrogen was utilized to perform a chamber leak test. Hydrogen was used as it is smaller than microbes, ensuring the leak tightness of the chamber. No leak was detected when testing the chamber door, connection points, and hardware locations (e.g. screws).
Repeatability Test The coefficient of variation (CV) of the number of particles detected across 10 replicates was calculated for each of the seven sampling locations within the chamber. This value was confirmed to be less than 10% in all cases.
Uniformity Test The chamber uniformity test involved nebulizing 0.8 micron PSL beads in the test chamber in accordance
with the JIS 3836 Annex 2 standard for evaluation of chamber uniformity. 4 A Kanomax 3900 particle counter was utilized to obtain 10, one-minute samples at each of seven locations within the chamber, including all five sampling locations in the base of the chamber and two air-sampler sampling port locations. The results of this test are shown in Figure 2. The mean number of particles detected at each of the seven locations was within a range of ± 10% of the average number of particles across all sampling locations.
00.10.20.30.40.50.60.70.80.9
11.1
S1 S2 S3 S4 S5 S6 S7Location
Nor
mal
ized
Par
ticle
Cou
nts
Figure 2: Aerosol test chamber static uniformity test. The red line marks the average normalized particle counts across all seven sampling locations. The blue lines represent plus and minus 10 percent of this average value.
Cleanliness Test An evaluation of the level of particle and biologic cleanliness in the chamber was performed. It was confirmed that the chamber complied with ISO Class 4 particulate levels and contained fewer than 1 cfu/m3.
Laser-Particle Visualization Evaluation A laser-particle visualization system from Shin Nippon Air Technologies was utilized to aid in the evaluation and confirmation of chamber homogeneity.
Test Acceptance Criteria In an effort to rigorously validate the IMD-A series as per USP <1223> and EP 5.1.6 guidelines, BioVigilant has actively communicated with the FDA and a biostatistician throughout the development of the test acceptance criteria due to broad guidance set forth in these documents, at times, and the interpretation required in comparing a new rapid microbiologic method to the traditional method. The following acceptance criteria were established under the guidance of a biostatistician and have been reviewed with biostatisticians at the FDA. In certain cases, such as when an alternate criterion enables evaluation of the statistical significance of the basic “≥ or ≤”
4 Japanese Industrial Standard: Testing methods for collection efficiency of airborne microbe samplers. JIS K 3836: 1995.
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comparison, alternative acceptance criteria were established. These alternate criteria were applied on an as-needed basis and are reported herein if utilized.
Accuracy The USP<1223> and EP 5.1.6 Accuracy metric is used to confirm that the IMD-A systems produce results equivalent to or better than those obtained by the traditional method. As stated in EP 5.1.6 and very similarly stated in USP <1223>, “at least five suspensions across the range of the test must be analyzed for each test micro-organism.” As such, five different concentrations across the operational range of the traditional method were analyzed for each of the five microbes tested. Furthermore, 12 replicates were performed at each titer to obtain a statistically relevant sample size. The Accuracy metric was assessed with the following primary and alternate acceptance criteria:
1. The mean, normalized IMD-A count for each organism and dilution is greater than or equivalent to 70% of the mean, normalized recovery of the reference air sampler.
2. If the primary criterion is not met, a statistical evaluation of the difference is performed using a T-test with a 95% confidence interval.
Precision The USP<1223> and EP 5.1.6 Precision metric is utilized to show that the IMD-A systems repeatedly produce results that are equivalent across multiple samplings, and to compare the degree of agreement between test results on the IMD-A systems to those of the reference method through the use of relative standard deviation (RSD) measurements. As stated in USP <1223>, “at least five suspensions across the range of the test should be analyzed. For each suspension at least 10 replicates should be assayed in order to be able to calculate statistically significant estimates of the standard deviation or relative standard deviation.” Again, data from 12 replicates for each of five suspensions across the range of the test have been used in the evaluation of Precision. The following primary and alternate acceptance criteria were applied in the analysis of Precision:
1. The RSD of the IMD-A system is less than or equal to the RSD of the reference air sampler (RAS).
2. If the RSDIMD-A>RSDRAS, a statistical calculation is performed to assess the relative Precision of the means between the IMD-A system and the air sampler(s).
Specificity 1 As stated in USP <1223>, and similarly stated in EP 5.1.6, the qualitative Specificity 1 metric assesses the ability of a quantitative microbiological method “to detect a range of microorganisms that may be present in the test article.” Consequently, five indicator microbes common to the pharmaceutical manufacturing environment were chosen for testing.
The Specificity 1 metric was assessed based on the following acceptance criteria:
1. The IMD-A systems produce quantitative (>50% detectability of replicates) results for each of the 5 concentrations tested for each microbe, which is corroborated by some level of positive growth for each reference instrument.
Limit of Detection The Limit of Detection (LOD) metric is utilized to determine the ability of the IMD-A systems to detect the presence of low numbers of microorganisms. Both USP <1223> and EP 5.1.6 recommend an LOD concentration that results in at least 50% of samples showing growth in the compendial test. The LOD titer, thus, is defined as the lowest titer resulting in at least 50% of replicates yielding growth. This was evaluated for each air sampler and IMD-A system with the following acceptance criteria:
1. The LOD of the IMD-A system is equal to or better than the LOD of the conventional air sampler(s).
Limit of Quantification Both USP <1223> and EP 5.1.6 define the limit of quantification (LOQ) as “the lowest number of microorganisms that can be accurately counted.” The LOQ is utilized to confirm that the IMD-A systems have an LOQ not greater than that of the reference method for environmental monitoring. This was assessed by comparing the lowest concentrations of microbes which could be accurately counted by the reference method and the IMD-A system to confirm that the IMD-A system was at least as sensitive at low microbial levels.
1. The LOQ of the IMD-A system is not greater than the LOQ for the conventional air sampler(s) tested, i.e. it is at least as sensitive as the traditional method.
Linearity The Linearity metric is employed to ensure that the IMD-A systems produce results that are proportional to the concentration of microorganisms present in a sample and equivalent to or better than results obtained by the reference method. Both USP <1223> and EP 5.1.6 recommend assessing a system’s linearity by calculating the coefficient of determination, R2, from a linear regression analysis of data obtained. A data set including at least five concentrations and a minimum of five replicates is recommended in USP <1223>. As such, 12 replicates at five different concentrations were evaluated for each IMD-A system and all three air samplers. The R2 values for all systems were calculated in reference to the particle counts obtained on the Kanomax particle counter.
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The following primary and alternate acceptance criteria were used:
1. The IMD-A system’s R2 value is greater than or equivalent to the reference air sampler’s R2 value.
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2. If the IMD-A system’s R2 value is less than the reference air sampler’s R2 value, the IMD-A R2 value should not be less than 0.90.
Range As defined in USP <1223> and EP 5.1.6, the operational range of a quantitative microbiological method is the interval between the upper and lower levels of microorganisms that have been demonstrated to be determined with Precision, Accuracy, and Linearity. Range is determined from the data acquired for Precision, Accuracy, and Linearity, and values are reported.
Robustness The Robustness test is utilized to show that the IMD-A systems are capable of operating within the temperature and humidity limits tested and that the change in operating parameters has little or no effect on their performance.
1. The performance of the IMD-A systems evaluated using reference particles stays within manufacturing tolerances across the operating conditions tested.
Ruggedness The Ruggedness assessments in USP <1223> and EP 5.1.6 are utilized to assess the repeatability in performance of like-model IMD-A systems and to confirm that the systems are intrinsically resistant to influences exerted by operational and environmental variables. In this regard, Ruggedness is defined as the degree of precision of test results, and a measure of relative standard deviation is used in the evaluation of data toward assessment of the Ruggedness metric. To provide context for interpretation, calculated RSD values may be compared to guidelines developed for the approximate expected RSD, as listed in the tables of Summary Test Results which follow. The following acceptance criterion was evaluated for Ruggedness:
1. Degree of precision of IMD-A test results obtained by analysis of the same samples under a variety of conditions is determined. The calculated RSD for datasets compared is reported.
Specificity 2 The quantitative Specificity 2 test is utilized to “challenge the alternative technology in a manner that would encourage false positive results.” As a result, the IMD-A systems were challenged with five common pharmaceutical cleanroom materials with the potential to elicit a fluorescence response on the IMD-A system and thus be considered interferents.
1. Evaluate the statistical significance between the mean biological counts observed during material testing and the biological counts observed during
background testing using a t-test with a 95% level of significance.
Test Results Summary Four IMD-A systems and three air samplers were challenged at five distinct concentrations, for five different organisms. All systems sampled air from the test chamber concurrently in order to provide the most accurate comparison possible.
Validation testing results are reported in the Summary Testing Result tables of this document. The IMD-A systems were found to be acceptable equivalents to the traditional methods.
IMD-A Passing Rate by Air Sampler
SAS MAS SMA
IMD‐A 300 Passing Rate 97 % 97% 97%
IMD‐A 350 Passing Rate 100% 99% 98%
• All IMD-A passing rates are within ±1% for the three air samplers tested.
LOQ Comparison testing: 345 comparison tests each 97% overall rate of passing The majority of metrics not passed were
related to Precision at low concentrations due to the disparity in flow rate between the IMD-A 300 (1.15 LPM) and SAS (100 LPM), MAS (100 LPM) and SMA (28.3 LPM) air samplers, and the low total microbial counts (low number statistics).
• All Robustness and Ruggedness tests passed • All Specificity 1 and Specificity 2 tests passed
LOQ Comparison testing: 345 comparison tests each 99% overall rate of passing
• All Robustness and Ruggedness tests passed • All Specificity 1 and Specificity 2 tests passed Low R2 values were observed for M. lylae on all IMD-A systems and air sampler instruments tested. M. lylae appears to be susceptible, both in terms of fluorescence and culturability, to stresses induced during nebulization, affecting the resulting linearity and precision measured by all samplers. For all other organisms, R2 values ≥ 0.90 were obtained.
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Met/exceeded acceptance criteria
Did not meet acceptance criteria for one IMD‐A system tested
Did not meet acceptance criteria for both (2) IMD‐A systems tested
Test Function Microbe T1 T2 T3 T4 T5 T1 T2 T3 T4 T5 T1 T2 T3 T4 T5
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus46% | 56%
43%22% | 19%
46% | 56% 18%
22% | 16% 17% | 9%46% | 56%
25% 17% | 14%
Escherichia coli 13% | 11%
Staphylococcus epidermidis29% | 26%
22%29% | 26%
21%
Micrococcus lylae 35% | 34% 35% | 31%
Corynebacterium afermentans 36% | 35%
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Met/exceeded acceptance criteriaDid not meet acceptance criteria
Test Function Tested Material70% IPA, WFI
Tryptic Soy BrothCleanroom Paper
Cleanroom Tyvek GownSilicone SprayRiboflavin
Normalized Counts< 10 [# particle/L or bio/L]10 ‐ 30 [# particle/L or bio/L]> 30 [# particle/L or bio/L]
Notes:
Operational Altitude Successfully tested to a barometric pressure equivalent to 6500 feet in altitudeSurvivability Environmental Successfully completed
¹ A single value is reported under Accuracy in instances where only one of the two IMD‐A 300 systems tested did not meet the acceptance criteria. Two values are representative of non‐passing values for bothIMD‐A 300 systems. A ≥ 70% acceptance criteria is required in order to meet the Accuracy metric.
² As with Accuracy, only non‐passing values are displayed for Precision.Two values indicate that only one IMD‐A system did not meet the Precision acceptance criteria, while three values indicate that both (2)IMD‐A 300 systems did not meet the Precision metric. In both cases the final number provided represents the air sampler %RSD for comparison.
* This RSD value does not necessarily apply to very low count environments. A higher RSD may be observed in environments where approximately < 2 particles/L are observed due to the minimal number of particles present in the environment and resulting small number statistics.
Robustness VerificationOperational Vibration Horizontal and vertical vibration testing successfully completed from 5Hz to 300Hz at 0.25g to 1.00g
R2IMD‐A 300 #1= 0.93 R
2IMD‐A 300 #2 = 0.90
< 13%< 21% < 9%
Summary of USP <1223> & Environmental Testing ResultsIMD‐A 300
Legend:
Operating temperature range of 15‐30°C, and operating humidity range of 10‐80% RH non‐condensing
R2IMD‐A 300 #1= 0.97 R
2IMD‐A 300 #2 = 0.95
R2IMD‐A 300 #1= 0.99 R
2IMD‐A 300 #2 = 0.99
R2IMD‐A 300 #1= 0.68 R
2IMD‐A 300 #2 = 0.61
R2IMD‐A 300 #1= 0.99 R
2IMD‐A 300 #2 = 0.99
Specificity Verification 2
R2IMD‐A 300 #1= 0.97 R
2IMD‐A 300 #2 = 0.95
R2IMD‐A 300 #1= 0.99 R
2IMD‐A 300 #2 = 0.99
R2IMD‐A 300 #1= 0.68 R
2IMD‐A 300 #2 = 0.61
Applies to the lowest concentration only
Applies to the lowest concentration only
Linearity (Underlined values do not meet criteria)
R2IMD‐A 300 #1= 0.95 R
2IMD‐A 300 #2 = 0.94
Applies to the lowest concentration only
Applies to the lowest concentration only
R2IMD‐A 300 #1= 1.00 R
2IMD‐A 300 #2 = 0.99
R2IMD‐A 300 #1= 0.97 R
2IMD‐A 300 #2 = 0.95
Applies to the lowest concentration only
R2IMD‐A 300 #1= 1.00 R
2IMD‐A 300 #2 = 0.99 R2
IMD‐A 300 #1= 1.00 R2IMD‐A 300 #2 = 0.99
Accuracy¹ (IMD‐A %)
Range
Precision² (%RSD)
Specificity 1
Limit of Detection
Limit of Quantification
R2IMD‐A 300 #1= 0.95 R
2IMD‐A 300 #2 = 0.94
R2IMD‐A 300 #1= 0.68 R
2IMD‐A 300 #2 = 0.61
Applies to the lowest concentration only
Legend:
SAS Super 100 (100LPM) MAS 100NT (100LPM) SMA
IMD‐A 300 Comparison to Three Air Samplers Over Five Concentrations
IMD‐A 300 ‐ Summary of USP <1223> & EP 5.1.6 Microbial Challenge Testing Results
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Met/exceeded acceptance criteria
Did not meet acceptance criteria for one IMD‐A system tested
Did not meet acceptance criteria for both (2) IMD‐A systems tested
Test Function Microbe T1 T2 T3 T4 T5 T1 T2 T3 T4 T5 T1 T2 T3 T4 T5
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans 62%
Bacillus atrophaeus
Escherichia coli17% | 18%
11%
Staphylococcus epidermidis 22% | 21%
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Bacillus atrophaeus
Escherichia coli
Staphylococcus epidermidis
Micrococcus lylae
Corynebacterium afermentans
Met/exceeded acceptance criteria
Did not meet acceptance criteriaTest Function Tested Material
70% IPA, WFITryptic Soy BrothCleanroom Paper
Cleanroom Tyvek GownSilicone SprayRiboflavin
Normalized Counts
< 10 [# particle/L or bio/L]10 ‐ 30 [# particle/L or bio/L]> 30 [# particle/L or bio/L]
Notes:
Analysis not possible on the IMD‐A 350 due to the flooding of system with silicone particles
Experimentally Determined RSD (%)
< 15%*< 3% < 1%
¹ A single value is reported under Accuracy in instances where only one of the two IMD‐A 350 systems tested did not meet the acceptance criteria. Two values are representative of non‐passing values for bothIMD‐A 350 systems. A ≥ 70% acceptance criteria is required in order to meet the Accuracy metric.
² As with Accuracy, only non‐passing values are displayed for Precision.Two values indicate that only one IMD‐A system did not meet the Precision acceptance criteria, while three values indicate that both (2)IMD‐A 350 systems did not meet the Precision metric. In both cases the final number provided represents the air sampler %RSD for comparison.
* This RSD value does not necessarily apply to very low count environments. A higher RSD may be observed in environments where approximately < 2 particles/L are observed due to the minimal number of particles present in the environment and resulting small number statistics.
Operating temperature range of 15‐30°C, and operating humidity range of 10‐80% RH non‐condensingHorizontal and vertical vibration testing successfully completed from 5Hz to 300Hz at 0.25g to 1.00g
Successfully tested to a barometric pressure equivalent to 6500 feet in altitudeSuccessfully completed
Operational Altitude
R2IMD‐A 350 #1= 0.95 R
2IMD‐A 350 #2 = 0.96
R2IMD‐A 350 #1= 0.99 R
2IMD‐A 350 #2 = 0.99
IMD‐A 350 Comparison to Three Air Samplers Over Five Concentrations
IMD‐A 350 ‐ Summary of USP <1223> & EP 5.1.6 Microbial Challenge Testing Results
Legend:
Legend: Summary of USP <1223> & Environmental Testing Results
