Environmental Testing |
The environmental conditions under which a product is manufactured can bear a direct relationship to the number and types of microorganisms in and on the finished product. Seasonal fluctuations, cleaning methods, employee training, room conditions and manufacturing changes all have the potential to dramatically influence the number and types of organisms recovered.
AppTec can assist with the design and interpretation of microbial sampling and environmental monitoring programs for cleanrooms or controlled environments.
In this section
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| Environmental Monitoring Programs |
| The goal of an environmental monitoring program is to reveal the microbial levels of controlled and critical areas and to assess the impact on the quality of the product. By determining the quantity and species of organisms present, manufacturers can design a program to ensure the effectiveness of various control measures, such as HEPA filtration, disinfection, maintenance, gowning and aseptic handling procedures. The experts at AppTec can help you design and implement such a program. AppTec can also supply equipment and products used in environmental monitoring. (See Page E-6.) AppTec offers 3 levels of service options.
The different levels are designed to meet a client’s particular needs. If you have a fully developed, ongoing environmental monitoring program and regularly analyze your own data, our Basic Program (Level 1) might be appropriate. The Intermediate Program (Level 2) might be appropriate if you have an established protocol and if, in addition to testing services, you want assistance in evaluating your data. Choosing the comprehensive program (Level 3) would be the best option if you want to ease the burden on your staff or if you have insufficient personnel or expertise to conduct a monitoring program. LEVEL 1 |
BASIC PROGRAM
We can provide you with the necessary materials and equipment. You follow your own protocol/plan in selecting and collecting your samples that you then send to us for testing. We provide you with the test results for your analysis.
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LEVEL 2 |
INTERMEDIATE PROGRAM
We can provide you with the necessary materials and equipment. You follow your own protocol/plan in selecting and collecting your samples that you then send to us for testing. We provide you with the test results and can provide you with a thorough analysis that includes evaluation of the data, trending and recommendations if necessary.
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LEVEL 3 |
COMPREHENSIVE PROGRAM
REMOTE: We consult with you and then design a custom monitoring program, including the sampling/testing plan as well as appropriate protocols. We can provide you with the necessary materials and equipment for collecting your samples that you then send to us for testing. We provide you with the test results and a thorough analysis that includes evaluation of the data, trending and recommendations if necessary.
ON-SITE: We come to your facility to consult with you and evaluate your specific needs. We then design a custom monitoring program, including the sampling/testing plan as well as appropriate protocols. We can provide you with the necessary materials and equipment for collecting your samples that you then send to us for testing. (We can also train your personnel in collection). We then perform the testing and provide you with a thorough analysis that will include evaluation of the data, trending and recommendations if necessary.
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Your AppTec Account Manager will provide you with initial information regarding an environmental program. Also working closely with you to help you design and set up your program will be an AppTec technical expert. The technical expert, highly trained and knowledgeable about environmental monitoring, will serve as your point person throughout the duration of your testing program.
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| Microbial Sampling Tests Back to Top |
| 1701000 | Growth on each environmental sample unit (either plates or strips) is enumerated. Gram stain and/or identification is available. SAMPLE REQUIREMENTS
Client provides air sample medium. No minimum. PREFERRED SHIPPING
Overnight air. Protect from temperature extremes. TURNAROUND TIME 7 days | | Environmental Air Sample |
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| 1702000 | Growth on each surface sample (either RODAC or swab sample) is enumerated. Gram stain and/or identification is available. SAMPLE REQUIREMENTS
Client provides surface sample medium. No minimum. PREFERRED SHIPPING
Overnight air. Protect from temperature extremes. TURNAROUND TIME 7 days | | Environmental Surface Sample |
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170300 - 100 mL
170400 - 1 mL | Sample aliquots obtained from a water system are evaluated for number of viable microorganisms in each 100 ml or 1 ml sample. SAMPLE REQUIREMENTS
100 ml or 1 ml sample in sterile sealable container.
(Client provides sterile collection containers.)
Keep refrigerated. PREFERRED SHIPPING
Overnight air on same day as collection.
Ship with 1-2 cold packs. TURNAROUND TIME 7 days |
Water System Microbial Counts |
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| 107500 | Samples are screened for coliform bacteria, a major intestinal bacterial pathogen. SAMPLE REQUIREMENTS
100 ml. Keep refrigerated. PREFERRED SHIPPING
Overnight air on same day as collection.
Ship with 1-2 cold packs. TURNAROUND TIME 4 days | | Water System Coliform Count |
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| 107501 | In this test, both Water System Microbial Counts (Test Code: 170300/170400) and Water System Coliform Counts (Test Code: 107500) are performed. SAMPLE REQUIREMENTS
100 ml. Keep refrigerated. PREFERRED SHIPPING
Overnight air on same day as collection.
Ship with 1-2 cold packs. TURNAROUND TIME 7 days | | Water System Microbial Counts and Water System Coliform Count |
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| Microbial Identification Tests Back to Top |
| 190601 | Differential staining technique used to categorize microorganisms. TURNAROUND TIME 2 days | | Gram Stain |
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| 190640 | Description of an organism's macroscopic appearance, including shape, color and texture. TURNAROUND TIME 2 days | | Colony Morphology |
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| 190630 | Description of an organism's macroscopic appearance, including shape, color and texture, plus differential staining to determine organism category. TURNAROUND TIME 2 days | Gram Stain and
Colony Morphology |
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| 190400 | Determination of the genus and species of a bacterial isolate. TURNAROUND TIME 3-14 days | | Bacterial Identification |
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| 190650 | Determination of the genus and species of a fungal isolate or genus and species identification of the Actinomyces. TURNAROUND TIME 10-14 days | | Fungi/Actinomyces Identification |
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| Environmental Testing Products Back to Top |
| 170500 | The RCS impact sampler is used in the detection of microbes in air samples from manufacturing zones. The impact sampler is able to determine the levels of aerobic-contamination by setting the flow rate to collect viable particles down to approximately 1 CFU/m3.
[See Environmental Air Sample test, Page E-4.] Sample Requirements
Client provides air sample medium. No minimum.
(Media can be purchased from AppTec.) | | Rental of RCS Impact Sampler |
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| 170501 | These strips have Tryptic Soy Agar (TSA) for isolation and cultivating a variety of aerobic microorganisms. | | RCS Impact Sampler Strips - Tryptic Soy Agar |
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| 170503 | These plates, with Tryptic Soy Agar (TSA) containing a neutralizing agent for quaternary ammonium compounds in sanitizers, are used for isolating and cultivating a variety of aerobic microorganisms. Surface sampling is used to determine the quality of routine cleaning and sanitization procedures. The RODAC method will semiquantify the amount of microbial content on the surface. [See Environmental Surface Sample test.] | RODAC Sample Plates -
Tryptic Soy Agar with Lecithin & Polysorbate 80 |
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