5002-221689-21506.pdf

2880 Bergey Road, Ste. K Hatfield, PA 19440

Control ID #: 5002-221689-21506

Date(s) Tested:

MAY 20, 2020

Field Service Technician(s):

ARIEL RESTO

Certification Report

Prepared for:

VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

Location Tested:

NUKE MED LAB

Presents:

www.envservices.com 800 - 345 - 6094

TABLE OF CONTENTS 2

SUMMARY REPORT 3

OVERVIEW 4

ANTE ROOM A13 AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 5

ANTE ROOM A13 PARTICLE COUNTS 6

NON-RADIATION LAB A13B AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 7

NON-RADIATION LAB A13B PARTICLE COUNTS 8

NUAIRE NU-PR797-400 S/N: 132391081309 MAIN CHAMBER PARTICLE COUNTS 9

NUAIRE NU-PR797-400 S/N: 132391081309 PASS THRU PARTICLE COUNTS 10

PRESSURIZATION ROOM PRESSURIZATION 11

NUAIRE NU-SNR-797-400 S/N: 132764090909 MAIN CHAMBER PARTICLE COUNTS 12

NUAIRE NU-SNR-797-400 S/N: 132764090909 PASS THRU PARTICLE COUNTS 13

NUAIRE NU-SNR-797-400 S/N: 132765090909 MAIN CHAMBER PARTICLE COUNTS 14

NUAIRE NU-SNR-797-400 S/N: 132765090909 PASS THRU PARTICLE COUNTS 15

RADIATION LAB A13A AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR 16

RADIATION LAB A13A PARTICLE COUNTS 17

TEST EQUIPMENT 18

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

2 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

TABLE OF CONTENTS

All testing is performed by qualified personnel using instrumentation, procedures and methods which ensure measurements observed are reliable. When specified, testing is performed in accordance with current ISO-17025, ISO-14644, USP-<797> and ENV's Quality Manual.

Specifications comply with applicable IEST recommended practices, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> Viable Environmental Sampling & Gowning Evaluation Current Version, and/or customer determined specifications when applicable. Measurement instruments used are traceable to The National Institute of Standards and Technology (NIST).

Results obtained apply to the specific room or equipment and are reflective of conditions at the time of this test.

ANTE ROOM A13

Test Test Result Specification Pass / Fail Comment

Total Air Changes / Hr. 20 N/A For Reference Only ISO Class ISO 8 @ 0.5µm ISO 8 @ 0.5µm PASS

NON-RADIATION LAB A13B

Test Test Result Specification Pass / Fail Comment

Total Air Changes / Hr. 33 N/A For Reference Only ISO Class ISO 7 @ 0.5µm ISO 7 @ 0.5µm PASS

NUAIRE NU-PR797-400 S/N: 132391081309 MAIN CHAMBER

Test Test Result Specification Pass / Fail Comment

ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

NUAIRE NU-PR797-400 S/N: 132391081309 PASS THRU

Test Test Result Specification Pass / Fail Comment ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

NUAIRE NU-SNR-797-400 S/N: 132764090909 MAIN CHAMBER

Test Test Result Specification Pass / Fail Comment

ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

NUAIRE NU-SNR-797-400 S/N: 132764090909 PASS THRU

Test Test Result Specification Pass / Fail Comment ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

NUAIRE NU-SNR-797-400 S/N: 132765090909 MAIN CHAMBER

Test Test Result Specification Pass / Fail Comment

ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

NUAIRE NU-SNR-797-400 S/N: 132765090909 PASS THRU

Test Test Result Specification Pass / Fail Comment ISO Class ISO 5 @ 0.5µm ISO 5 @ 0.5µm PASS

PRESSURIZATION

Test Test Result Specification Pass / Fail Comment

Rad lab a13a to ante room: Negative | 0.109 N/A For Reference Only Non rad lab a13b to ante room: Negative | 0.092 N/A For Reference Only

Ante room to chemo room: Positive | 0.029 N/A For Reference Only

RADIATION LAB A13A

Test Test Result Specification Pass / Fail Comment Total Air Changes / Hr. 32 N/A For Reference Only

ISO Class ISO 8 @ 0.5µm ISO 8 @ 0.5µm PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

3 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

SUMMARY REPORT

VACHS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

4 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

OVERVIEW

No. of Readings

Total Air Supply Volume

Room Air Changes/Hour

Room ACH Specification

Total ACH Specification

Total Air Changes/Hour

Room Volume

N/A

N/A

Test Result For Reference Only

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

5 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR

(UNITS IN CUBIC FEET PER MINUTE) - OPERATIONAL / DYNAMIC

AT 0.5 MICRONS AND LARGER

* ISO Class 8 allows a maximum of 3520000 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

228 169 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

8052 5964 N/A8 8

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

16.09

173.16

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

6 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

OPERATIONAL / DYNAMIC

Room Air Changes/Hour

Room ACH Specification

Total ACH Specification

Total Air Changes/Hour

Room Volume

N/A

N/A

Test Result For Reference Only

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

7 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR

NON-RADIATION LAB A13B

* ISO Class 7 allows a maximum of 352000 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

82 51 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

2896 1815 N/A5 7

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

8.38

90.17

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

8 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

NON-RADIATION LAB A13B

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

0 0 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

0 0 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.56

6.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

9 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

NON-RADIATION LAB A13B - NUAIRE NU-PR797-400 S/N: 132391081309 MAIN CHAMBER

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

0 0 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

0 0 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.19

2.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

10 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

NON-RADIATION LAB A13B - NUAIRE NU-PR797-400 S/N: 132391081309 PASS THRU

Test Result For Reference Only

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

11 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

ROOM PRESSURIZATION

(UNITS IN INCHES WATER GAUGE) - OPERATIONAL / DYNAMIC

PRESSURIZATION

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

6 2 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

212 64 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.56

6.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

12 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

RADIATION LAB A13A - NUAIRE NU-SNR-797-400 S/N: 132764090909 MAIN CHAMBER

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

0 0 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

0 0 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.19

2.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

13 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

RADIATION LAB A13A - NUAIRE NU-SNR-797-400 S/N: 132764090909 PASS THRU

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

4 1 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

141 35 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.56

6.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

14 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

RADIATION LAB A13A - NUAIRE NU-SNR-797-400 S/N: 132765090909 MAIN CHAMBER

* ISO Class 5 allows a maximum of 3520 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

5 2 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

177 57 N/A5 5

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

0.19

2.00

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

15 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

RADIATION LAB A13A - NUAIRE NU-SNR-797-400 S/N: 132765090909 PASS THRU

Room Air Changes/Hour

Room ACH Specification

Total ACH Specification

Total Air Changes/Hour

Room Volume

N/A

N/A

Test Result For Reference Only

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

16 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

AIR SUPPLY VOLUMES & AIR CHANGES PER HOUR

RADIATION LAB A13A

* ISO Class 8 allows a maximum of 3520000 particles 0.5 per cubic meter as an average count at any location as long as the entire clean area meets the required statistical tests.

106 65 N/A

Number of Locations

Highest concentration

Average concentration 95% UCL ISO Class

Resulting ft³ m³ ft³ m³ ft³ m³

3743 2278 N/A6 8

AT 0.5 MICRONS AND

LARGER

Particulate Sampled

Sample Volume

1.00 ft³

0.03 m³

28.32 ℓ

10.92

117.56

ISO Target Class

Area(m²)

Area(ft²)

The above referenced clean zone has successfully passed the minimum requirements to meet the class listed below per ISO Standard 14644-1:2015 for particle count testing of cleanrooms and associated controlled environments.

Test Result

PASS

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

17 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

PARTICLE COUNTS

RADIATION LAB A13A

Manufacturer Model Serial Calibration Due DateEquipment Name

PARTICLE COUNTER

LIGHTHOUSE

WORLDWIDE

SOLUTIONS

SOLAIR 3100 200104019 16 JAN 21

PHOTOMETER ATI 2H 20511 27 MAR 21

ELECT. BALANCING TOOL ALNOR EBT721 91018023 20 AUG 20

Test equipment calibration certificates available upon request.

Company ID: TX0242-009 Unique ID: 569830

ENV SERVICES, Inc.

PROVIDING NATIONWIDE SOLUTIONS, CERTIFICATION, CALIBRATION, VALIDATION, CLEANROOMS

Project: VACHS

10 CASIA STREET (119)

SAN JUAN, PR 00921

18 of 18Test Date: May 20, 2020 Control ID #: 5002-221689-21506

TEST EQUIPMENT

NUKE MED LAB