™

PACE Evaluation
Technical Report

August 31, 2016

PREPARED EXPRESSLY FOR: Ultra-Laboratories SA de CV

Guadalajara
Dr. R. Michel 2920 Parque Industrial el Alamo
Guadalajara
Jalisco, 4490
Mexico
Jose Manuel Mariscal
Validation Manager

PACE: #6H045050

REQUESTED BY: Liliana Mora

STERIS Corporation
Scientific Sales Representative

LABORATORY PROCESSING DIRECTED BY:

Scott Thompson Paul Lopolito

Technical Services Senior Technical Services
Associate Manager

PROJECT DESCRIPTION

Determine the parameters needed for the removal of:

PACE #6H045, Epirubicina
PACE #6H046, Oxaliplatino
PACE #6H047, Irinotecan
PACE #6H048, Pemetrexed
PACE #6H049, Paclitaxel
PACE #6H050, Docetaxei

from stainless steel surfaces by agitated immersion and manual scrub at ambient temperature.

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 2

PROCEDURE

1. Dry, clean stainless steel coupons were weighed on an analytical balance to measure the
pre-coating weight of the coupons.
2. The coupons were coated with 3-5 mL of sample.
3. The samples were air-dried at ambient temperature for at least 48 hours.
4. The coupons were weighed on an analytical balance and the dry coating weights of the
sample residues were determined.
5. The coupons were cleaned by agitated immersion and manual scrub; (descriptions are listed
below). Temperature was maintained thorough out the cleaning method.
6. The coupons were removed and visually observed for cleanliness.
7. The coupons were rinsed on each side with tap water for 10 seconds at a flow rate of 0.5
gal/min (1.9L/min).
8. The coupons were rinsed on each side with de-ionized water and examined for a water
break-free surface.
9. The coupons were air-dried at ambient temperature and visually observed for cleanliness.
10. The coupons were weighed on an analytical balance and the post-cleaning weights of the
sample residues were determined.

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 3

CLEANING METHOD DESCRIPTION

a. Coupon Cleaning by Agitated Immersion

Coated coupon is immersed in a 1500 mL beaker filled with a cleaning solution and the solution is
agitated at a mild speed using a magnetic stirrer. Typically, the coupon remains in the agitated solution for
15 minutes (unless notified by customer otherwise); then the coupon is evaluated
b. Manual Cleaning Using a Brush or a Wipe
A coated coupon is held with forceps and lightly scrubbed with a nylon-bristled brush or wiped with a
polyester wipe on the coated side using the cleaning solution for up to 60 seconds; a longer time period
may be required.

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 4

ACCEPTANCE CRITERIA DESCRIPTION

Cleanliness Criteria for Stainless Steel Coupons

A coupon is considered to be clean if (1) it is visually clean, (2) water break-free and (3) the measured
residual weight is less than 0.1 mg.

Visually Clean: A coupon is considered visually clean if no residue is detected by the unaided eye.

Water Break-Free: A coupon is considered water break-free if no breaks in the water surface are detected after 30
- 60 seconds from the beginning of the test. The coupon is placed in vertical position, and its surface is
flushed with deionized water, using a squeeze bottle. The surface is examined as the film of water drains. If
the surface is clean, the water will form a continuous film that uniformly drains from the surface.

Residual Weight: Residual weight must be less than 0.1 mg. A washed coupon is air-dried at ambient temperature
and then weighed on an analytical balance. This weight is compared with the initial weight for the dry clean
coupon before coating with a sample.

Cleanliness Criteria for Other Substrates

A coupon is considered to be clean if it is visually clean.

Water Break-Free and Residual Weight criteria are used for other substrates when appropriate.

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 5

CONCLUSIONS AND RECOMMENDATIONS

PACE #6H045
Epirubicina
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H045, Epirubicina

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon Weight
Agitated Immersion
CIP 100 detergent, 0.0584 g
78.9864 g 60 cm2 78.9864 g 0.0 mg
1 % v/v, ambient temp, 0.97 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.1214 g
79.1399 g 50 cm2 79.1399 g 0.0 mg
1 % v/v, ambient temp, 2.43 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 6
PACE #6H046
Oxaliplatino
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H046, Oxaliplatino

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon Weight
Agitated Immersion
CIP 100 detergent, 0.0059 g
79.3161 g 72 cm2 79.3161 g 0.0 mg
1 % v/v, ambient temp, 0.08 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.0069 g
79.3664 g 55 cm2 79.3664 g 0.0 mg
1 % v/v, ambient temp, 0.13 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 7

PACE #6H047
Irinotecan
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H047, Irinotecan

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon Weight
Agitated Immersion
CIP 100 detergent, 0.0047 g
79.3839 g 63 cm2 79.3839 g 0.0 mg
1 % v/v, ambient temp, 0.08 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.0072 g
79.0812 g 70 cm2 79.0812 g 0.0 mg
1 % v/v, ambient temp, 0.10 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 8

PACE #6H048
Pemetrexed
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H048, Pemetrexed

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon Weight
Agitated Immersion
CIP 100 detergent, 0.0302 g
79.1326 g 66 cm2 79.1326 g 0.0 mg
1 % v/v, ambient temp, 0.46 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.0396 g
79.1329 g 70 cm2 79.1329 g 0.0 mg
1 % v/v, ambient temp, 0.57 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 9

PACE #6H049
Paclitaxel
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H049, Paclitaxel

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon
Weight
Agitated Immersion
CIP 100 detergent, 0.7147 g
79.5414 g 112.5 cm2 79.5414 g 0.0 mg
1 % v/v, ambient temp, 6.35 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.7800 g
79.2786 g 105 cm2 79.2786 g 0.0 mg
1 % v/v, ambient temp, 7.43 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 10

PACE #6H050
Docetaxei
Air-dried at Ambient Temperature for 48 hours

The residue was effectively removed from stainless steel by agitated immersion using a
solution of 1% v/v CIP 100 detergent at ambient temperature for 15 minutes.

The residue was effectively removed from stainless steel by manual scrub using a solution of
1% v/v CIP 100 detergent at ambient temperature for 5-minute soak and a 30 second scrub.

COUPON COATING DATA

PACE #6H050, Docetaxei

Air Dried at Ambient Temperature for 48 hours
Process Pre-coating Coated Dry Coating Post-cleaning Residue
Coupon Weight Area Weight Coupon Weight
Agitated Immersion
CIP 100 detergent, 0.4311 g
79.1792 g 91 cm2 79.1792 g 0.0 mg
1 % v/v, ambient temp, 4.75 mg/cm2
15 min
Manual Scrub
CIP 100 detergent, 0.3596 g
79.0949 g 90 cm2 79.0949g 0.0 mg
1 % v/v, ambient temp, 4.00 mg/cm2
5 min soak, 30 sec scrub

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 PACE Evaluation
Technical Report

PACE #6H045050
Page 11

In addition to the Technical Data Sheets listing all pertinent information regarding the use of CIP
100® Alkaline Detergent we are also including “Data Charts” listing the tests conducted in our
laboratory. After reviewing this report, if you have any questions or if we can be of further
assistance, please feel free to contact us.

All STERIS products must be handled in accordance with labeling and SDS instruction

Sincerely,

Scott Thompson Paul Lopolito

Technical Services Associate Senior Technical Services Manager

STERIS Corporation
SCIENTIFIC Division
PO Box 147
St. Louis, MO 63166-0147 USA
1-800-345-0802 CONFIDENTIAL
 Ultra-Labs
PACE #6H045, Epirubicina
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH ® 10 min soak-1min scrub
1% v/v Visually Clean Yes
detergent Ambient Temp

3" x 6" STAINLESS STEEL COUPONS UNLESS OTHERWISE NOTED

Attachment A, Page 12
 Ultra-Labs
PACE #6H045, Epirubicina
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon

Attachment A, Page 13
 Ultra-Labs
PACE #6H046, Oxaliplatino
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
1% v/v Light Residue No
detergent Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
3% v/v Light Residue No
detergent Ambient Temp

Attachment A, Page 14
 Ultra-Labs
PACE #6H046, Oxaliplatino
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon

Attachment A, Page 15
 Ultra-Labs
PACE #6H047, Irinotecan
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
1% v/v Light Residue No
detergent Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
3% v/v Light Residue No
detergent Ambient Temp

Attachment A, Page 16
 Ultra-Labs
PACE #6H047, Irinotecan
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon

Attachment A, Page 17
 Ultra-Labs
PACE #6H048, Pemetrexed
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
1% v/v Visually Clean Yes
detergent Ambient Temp

Attachment A, Page 18
 Ultra-Labs
PACE #6H048, Pemetrexed
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon

Attachment A, Page 19
 Ultra-Labs
PACE #6H049, Paclitaxel
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
1% v/v Visually Clean Yes
detergent Ambient Temp

Attachment A, Page 20
 Ultra-Labs
PACE #6H049, Paclitaxel
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon
Attachment A, Page 21
 Ultra-Labs
PACE #6H050, Docetaxei
Air Dried at Ambient Temperature for 48 hours
______________________________

Agitated Immersion
TIME/ VISUAL WATER
CLEANER CONC.
TEMPERATURE OBSERVATION BREAK-FREE
CIP 100 detergent 1% v/v 15 min / Ambient Temp Visually Clean Yes

Manual Scrub
CLEANER CONC. TIME/ VISUAL WATER
TEMPERATURE OBSERVATION BREAK-FREE
5 min soak-30 sec scrub
CIP 100 detergent 1% v/v Visually Clean Yes
Ambient Temp
ProKlenz NpH 10 min soak-1min scrub
1% v/v Visually Clean Yes
detergent Ambient Temp

Attachment A, Page 22
 Ultra-Labs
PACE #6H050, Docetaxei
Air Dried at Ambient Temperature for 48 hours
______________________________

Coated Coupon

Attachment A, Page 23
bcc: Liliana Mora
Wanda Jimenez
Paul Lopolito
PACE #6H045050

Attachment A, Page 24