u.s. micro-solutions, inc. * 1075 south main street, suite ......sep 19, 2018 · customer name:...
TRANSCRIPT
Customer Name:
Customer Address:
Customer Phone:
PO Number:
Project Name/Number:
%Raw
CTs
< 1
5 2
1 < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
1F < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
< 1
5 2
3 < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
3F < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
Media: Manufacturer:
TSA w/Lec Poly 80
SDA w/Lec Poly 80
Remel
Remel
11/01/18
10/16/18
in any area is considered not to be in compliance and immediate remediation and investigation into the cause must be conducted.
Notation for Bolded Microbes
Viable sampling was conducted while the cleanroom was in an active or dynamic state.
SAS 180 219
USP<797> Pharmaceutical Compounding-Sterile Preparations states recovery of any mold, yeast, coagulase-positive Staphylococcus, or gram-negative rod
376649
LAFW 66043233 Total Microbial Count
98091-18
(262) 639-6796
Sample Date:
Fax:
91218 Attention:
LAFW 89056814
Total Bacterial Count:
Total Microbial Count
CFU/m³ of air
CFU/m³ of air
Total Fungal Count:
No growth
Analytical Sensitivity:
CFU/m³ of air
1
CFU/m³ of air
No growth
Phone: (877) 876-4276 Fax: (724) 853-4049 AIHA-LAP, LLC EMLAP #103009
Customer sample numbers below are uniquely identified by prefixing Laboratory #:
Northern Air Flow
PO Box 085595
Racine, WI 53408 September 19, 2018
Pore Correction Factor
CFU/m³ of airTotal Bacterial Count:
U.S. Micro-Solutions, Inc. * 1075 South Main Street, Suite 104 * Greensburg, PA 15601
No of Personnel in Room:
Bioaerosol Sample Set(s) for Bacterial & Fungal Analysis - Analytical Method USMS-G065
Results of Microbial Analysis
September 12, 2018
September 13, 2018Date Received:
No growth
Pore Correction Factor
Sample Description /
Sample Number
www.usmslab.com
ISO Class
CFU/m³ of air
Bac
teri
a
Date of Report:
The Compounder
Viable Air Level: Count Below Action Level
CFU/m³ of air
Tom Mikulecky
Pore Correction Factor
Pore Correction Factor
Total Fungal Count:
Fu
ng
i
1
ISO Class Viable Air Level:
Analytical Sensitivity: CFU/m³ of air
Count Below Action Level
No growth
No of Personnel in Room:
Herbert Layman, BS, SM, CIEC
Technical Manager:
Results relate only to the samples tested. Results are reported as calculated. For biological data, the first and/or second digit should be considered significant.
*Fungus (mold, yeast)
When providing duplicates of this report, the document should be provided in total and not in section in accordance with AIHA-LAP, LLC. Any unauthorized or improper disclosure, copying, distribution, use, or falsification of these results is
prohibited. USMS shall have no liability to the Customer or the Customer’s customer for opinions stated, recommendations made, actions taken, or conduct implemented based on the test results reported.
CFU/m³ of air
Bac
teri
aF
un
gi
Analytical Sensitivity: 1
1Analytical Sensitivity:
CFU/m³ of air
Air Sampler: Impaction Head (# of holes) Lot Number: Exp. Date:
386876
Bioaerosol Set(s) for Bacterial and Fungal Analysis Page 1 of 6
Customer Name:
Customer Address:
Customer Phone:
PO Number:
Project Name/Number:
%Raw
CTs
< 1
7 2
5 < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
5F < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
< 1
8 2
7 < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
7F < 1
Total Raw Count: <1
Total Volume: 1000 liters of air
0
Northern Air Flow
PO Box 085595
Racine, WI 53408
Sample Date: September 12, 2018
Date Received: September 13, 2018
Date of Report: September 19, 2018
U.S. Micro-Solutions, Inc. * 1075 South Main Street, Suite 104 * Greensburg, PA 15601
Phone: (877) 876-4276 Fax: (724) 853-4049 AIHA-LAP, LLC EMLAP #103009www.usmslab.com
The Compounder
Customer sample numbers below are uniquely identified by prefixing Laboratory #: 98091-18
Bioaerosol Sample Set(s) for Bacterial & Fungal Analysis - Analytical Method USMS-G065
Sample Description /
Sample NumberResults of Microbial Analysis
(262) 639-6796 Fax:
91218 Attention: Tom Mikulecky
CFU/m³ of air
No growth
IV Room Total Microbial Count CFU/m³ of air
ISO Class Viable Air Level: Count Below Action Level No of Personnel in Room:
Analytical Sensitivity: 1 CFU/m³ of airPore Correction Factor
Bac
teri
a
Total Bacterial Count:
Ante Area Total Microbial Count CFU/m³ of air
ISO Class Viable Air Level: Count Below Action Level No of Personnel in Room:
Analytical Sensitivity: 1 CFU/m³ of airPore Correction Factor
Fu
ng
i
Total Fungal Count: CFU/m³ of air
No growth
Bac
teri
a
Total Bacterial Count: CFU/m³ of air
No growth
Analytical Sensitivity: 1 CFU/m³ of airPore Correction Factor
Air Sampler: Impaction Head (# of holes) Media: Manufacturer: Lot Number: Exp. Date:
Analytical Sensitivity: 1 CFU/m³ of airPore Correction Factor
Fu
ng
i
Total Fungal Count: CFU/m³ of air
No growth
SDA w/Lec Poly 80 Remel 376649 10/16/18
SAS 180 219 TSA w/Lec Poly 80 Remel 386876 11/01/18
Technical Manager:
Herbert Layman, BS, SM, CIEC
Viable sampling was conducted while the cleanroom was in an active or dynamic state.
Notation for Bolded Microbes
USP<797> Pharmaceutical Compounding-Sterile Preparations states recovery of any mold, yeast, coagulase-positive Staphylococcus, or gram-negative rod
in any area is considered not to be in compliance and immediate remediation and investigation into the cause must be conducted.
Results relate only to the samples tested. Results are reported as calculated. For biological data, the first and/or second digit should be considered significant.
*Fungus (mold, yeast)
When providing duplicates of this report, the document should be provided in total and not in section in accordance with AIHA-LAP, LLC. Any unauthorized or improper disclosure, copying, distribution, use, or falsification of these results is
prohibited. USMS shall have no liability to the Customer or the Customer’s customer for opinions stated, recommendations made, actions taken, or conduct implemented based on the test results reported.
Bioaerosol Set(s) for Bacterial and Fungal Analysis Page 2 of 6
Customer Name:
Customer Address:
Customer Phone:
PO Number:
Project Name/Number:
%Raw
CTs
< 1
5 2
2< 1
Total Raw Count: <1
2F < 1
Total Raw Count: <1
< 1
5 2
4 < 1
Total Raw Count: <1
4F < 1
Total Raw Count: <1
Media: TSA w/Lec Poly 80
Lot Number:
LAFW 89056814
No growth
(262) 639-6796
Tom MikuleckyAttention:
Northern Air Flow
PO Box 085595
Racine, WI 53408
Fax:
September 13, 2018
www.usmslab.com
Total Fungal Count:
Technical Manager:
LAFW 66043233
No growth
Total Bacterial Count:
Total Microbial Count
Viable Surface Level:
Results relate only to the samples tested. Results are reported as calculated. For biological data, the first and/or second digit should be considered significant.
*Fungus (mold, yeast)
When providing duplicates of this report, the document should be provided in total and not in section in accordance with AIHA-LAP, LLC. Any unauthorized or improper disclosure, copying, distribution, use, or falsification of these results is
prohibited. USMS shall have no liability to the Customer or the Customer’s customer for opinions stated, recommendations made, actions taken, or conduct implemented based on the test results reported.
Fu
ng
i
Total Bacterial Count:
USP<797> Pharmaceutical Compounding-Sterile Preparations states recovery of any mold, yeast, coagulase-positive Staphylococcus, or gram-negative rod
Analytical Sensitivity:
The Compounder
September 12, 2018
U.S. Micro-Solutions, Inc. * 1075 South Main Street, Suite 104 * Greensburg, PA 15601
Date Received:
98091-18
91218
Date of Report:
Contact Plate Set(s) for Bacterial & Fungal Analysis - Analytical Method USMS-G065
Results of Microbial Analysis
Phone: (877) 876-4276 Fax: (724) 853-4049 AIHA-LAP, LLC EMLAP #103009
Customer sample numbers below are uniquely identified by prefixing Laboratory #:
Sample Description /
Sample Number
Sample Date:
September 19, 2018
CFU/plateAnalytical Sensitivity:
386876
1
Media: SDA w/Lec Poly 80 Remel
376649
Exp Date:
10/16/18
Lot Number:
Remel
Exp Date:
11/01/18
Manufacturer:Manufacturer:
CFU/plate
Viable Surface Level: Count Below Action Level
No growth
Total Microbial Count
CFU/plate
CFU/plate
1
Analytical Sensitivity:
No of Personnel in Room:
1
ISO Class
No of Personnel in Room:
Bacte
ria
CFU/plate
ISO Class
Analytical Sensitivity:
Bacte
ria
CFU/plate
Herbert Layman, BS, SM, CIEC
in any area is considered not to be in compliance and immediate remediation and investigation into the cause must be conducted.
Notation for Bolded Microbes
CFU/plate
CFU/plate
Viable sampling was conducted while the cleanroom was in an active or dynamic state.
CFU/plate
1
No growth
Count Below Action Level
Fu
ng
i
Total Fungal Count:
CFU/plate
Contact Plate Set(s) for Bacterial and Fungal Analysis Page 3 of 6
Customer Name:
Customer Address:
Customer Phone:
PO Number:
Project Name/Number:
%Raw
CTs
< 1
7 2
6< 1
Total Raw Count: <1
6F < 1
Total Raw Count: <1
< 1
8 2
8 < 1
Total Raw Count: <1
8F < 1
Total Raw Count: <1
Media: TSA w/Lec Poly 80
Lot Number:
(262) 639-6796 Fax:
91218 Attention: Tom Mikulecky
U.S. Micro-Solutions, Inc. * 1075 South Main Street, Suite 104 * Greensburg, PA 15601
Phone: (877) 876-4276 Fax: (724) 853-4049 AIHA-LAP, LLC EMLAP #103009www.usmslab.com
Northern Air Flow
PO Box 085595
Racine, WI 53408
Sample Date: September 12, 2018
Date Received: September 13, 2018
Date of Report: September 19, 2018
IV Room Total Microbial Count CFU/plate
ISO Class Viable Surface Level: Count Below Action Level No of Personnel in Room:
The Compounder
Customer sample numbers below are uniquely identified by prefixing Laboratory #: 98091-18
Contact Plate Set(s) for Bacterial & Fungal Analysis - Analytical Method USMS-G065
Sample Description /
Sample NumberResults of Microbial Analysis
Bacte
ria
Total Bacterial Count: CFU/plate
No growth
CFU/plate
No growth
Analytical Sensitivity: 1 CFU/plate
Analytical Sensitivity: 1 CFU/plate
Fu
ng
i
Total Fungal Count:
CFU/plate
No growth
Ante Area Total Microbial Count CFU/plate
ISO Class Viable Surface Level: Count Below Action Level No of Personnel in Room:
Analytical Sensitivity: 1 CFU/plate
Bacte
ria
Total Bacterial Count:
Fu
ng
i
Total Fungal Count: CFU/plate
No growth
Analytical Sensitivity: 1 CFU/plate
Lot Number: Exp Date: Exp Date:
386876 11/01/18 376649 10/16/18
Manufacturer: Remel Media: SDA w/Lec Poly 80 Manufacturer: Remel
Herbert Layman, BS, SM, CIEC
Viable sampling was conducted while the cleanroom was in an active or dynamic state.
Notation for Bolded Microbes
USP<797> Pharmaceutical Compounding-Sterile Preparations states recovery of any mold, yeast, coagulase-positive Staphylococcus, or gram-negative rod
in any area is considered not to be in compliance and immediate remediation and investigation into the cause must be conducted.
Results relate only to the samples tested. Results are reported as calculated. For biological data, the first and/or second digit should be considered significant.
*Fungus (mold, yeast)
When providing duplicates of this report, the document should be provided in total and not in section in accordance with AIHA-LAP, LLC. Any unauthorized or improper disclosure, copying, distribution, use, or falsification of these results is
prohibited. USMS shall have no liability to the Customer or the Customer’s customer for opinions stated, recommendations made, actions taken, or conduct implemented based on the test results reported.
Technical Manager:
Contact Plate Set(s) for Bacterial and Fungal Analysis Page 4 of 6
Customer Name:
Customer Address:
Customer Phone:
PO Number:
Project Name/Number:
%Raw
CTs
####
Positive Control #####
<1
Positive Control #####
<1
####
Negative Control* #####
Negative Control* #####
Northern Air Flow
PO Box 085595
Racine, WI 53408
Sample Date: September 12, 2018
Date Received: September 13, 2018
Date of Report: September 19, 2018
U.S. Micro-Solutions, Inc. * 1075 South Main Street, Suite 104 * Greensburg, PA 15601
Phone: (877) 876-4276 Fax: (724) 853-4049 AIHA-LAP, LLC EMLAP #103009www.usmslab.com
The Compounder
Customer sample numbers below are uniquely identified by prefixing Laboratory #: 98091-18
Media Control(s) for Bacterial & Fungal Analysis - Analytical Method USMS-G065
Sample Description /
Sample NumberResults of Microbial Analysis
(262) 639-6796 Fax:
91218 Attention: Tom Mikulecky
Growth of Staphylococcus aureus
Growth of Pseudomonas aeruginosa
Growth of Bacillus subtilis
Positive Control Total Microbial Count CFU/m³ of air
#DIV/0!
Bacte
ria
Negative Control Total Microbial Count CFU/m³ of air#DIV/0! No of Personnel in Room:
#DIV/0!
Fu
ng
i
Growth of Aspergillus brasiliensis
Growth of Candida albicans
Bacte
ria
No growth*
*Results are not blank corrected
#DIV/0!
Media: Manufacturer: Lot Number: Exp. Date:
*Results are not blank corrected
#DIV/0!
Fu
ng
i
No growth*
SDA w/Lec Poly 80 Remel 376649 10/16/18
TSA w/Lec Poly 80 Remel 386876 11/01/18
Technical Manager:
Herbert Layman, BS, SM, CIEC
Notation for Bolded Microbes
USP<797> Pharmaceutical Compounding-Sterile Preparations states recovery of any mold, yeast, coagulase-positive Staphylococcus, or gram-negative rod
in any area is considered not to be in compliance and immediate remediation and investigation into the cause must be conducted.
Results relate only to the samples tested. Results are reported as calculated. For biological data, the first and/or second digit should be considered significant.
When providing duplicates of this report, the document should be provided in total and not in section in accordance with AIHA-LAP, LLC. Any unauthorized or improper disclosure, copying, distribution, use, or falsification of these results is
prohibited. USMS shall have no liability to the Customer or the Customer’s customer for opinions stated, recommendations made, actions taken, or conduct implemented based on the test results reported.
Bioaerosol Set(s) for Bacterial and Fungal Analysis Page 5 of 6
Laboratory Report #
*End of Report*
98091-18
Page 6 of 6 plus COC
