Humanwell Pharmaceutical Ethiopia PLC

Form No.: SOP/SL/003/F/01

Disinfectants Validation Report Form

Attachment (A)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier:

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Filtration Technique

Acceptance
Organism Criteria Result

Pseudomonas aeruginosa ATTCC Six-log reduction

9027 within 5 minutes

Escherichia coli ATCC 8739 Six-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Six-log reduction

within 5 minutes

Staphylococcus aureus ATCC 6538 Six-log reduction

within 5 minutes

Clostridium sporogenes ATCC 11437 Six-log reduction

within 5 minutes

Candida albicans ATCC 10231 Six-log reduction

within 5 minutes
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Aspergillus niger ATCC 16404 Six-log reduction

within 5 minutes

Environmental isolates from wall Six-log reduction

(micrococcus lutes) within 5 minutes

Environmental isolates from operator’s Six-log reduction

fingerprint (Bacillus spp.) within 5 minutes

Environmental isolates from floor Six-log reduction

(Aspergillus) within 5 minutes

Environmental isolates from glass Six-log reduction

window (Staphylococcus epidermis) within 5 minutes

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (B)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Surface Technique
Efficacy Test on Wall (Sandwich Panel) (Coupons)

Acceptance
Organism Criteria Result

Pseudomonas aeruginosa Three-log

ATTCC 9027 reduction within
5 minutes

Escherichia coli ATCC 8739 Three-log

reduction within
5 minutes

Bacillus subtilis ATCC 6633 Three-log

reduction within
5 minutes
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Staphylococcus aureus ATCC Three-log

6538 reduction
within 5 minutes

Clostridium sporogenes ATCC Three-log

11437 reduction within
5 minutes

Candida albicans ATCC 10231 Three-log

reduction within
5 minutes

Aspergillus niger ATCC 16404 Three-log

reduction within
5 minutes

Environmental isolates from wall Three-log

(micrococcus lutes) reduction within
5 minutes

Environmental isolates from Three-log

oper- reduction within
ator’s fingerprint (Bacillus spp.) 5 minutes

Environmental isolates from floor Three-log

(Aspergillus) reduction within
5 minutes

Environmental isolates from glass Three-log

window (Staphylococcus reduction within
epidermis) 5 minutes

Analyzed by: Microbiologist Checked by: QC Manager

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (C)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Ceiling (Cleanroom Design) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction

ATTCC 9027 within 5 minutes

Escherichia coli ATCC 8739 Three-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction

within 5 minutes

Staphylococcus aureus ATCC Three-log reduction

6538 within 5 minutes

Clostridium sporogenes Three-log reduction

ATCC 11437 within 5 minutes

Candida albicans ATCC Three-log reduction

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

10231 within 5 minutes

Aspergillus niger ATCC Three-log reduction

16404 within 5 minutes

Environmental isolates from Three-log reduction

wall (micrococcus lutes) within 5 minutes

Environmental isolates from Three-log reduction

oper-ator’s fingerprint within 5 minutes
(Bacillus spp.)

Environmental isolates from Three-log reduction

floor (Aspergillus) within 5 minutes

Environmental isolates from Three-log reduction

glass window within 5 minutes
(Staphylococcus epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (D)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test Doors (Galvanized Steel Finished with White Powder) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction

ATTCC 9027 within 5 minutes

Escherichia coli ATCC 8739 Three-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction

within 5 minutes

Staphylococcus aureus ATCC Three-log reduction

6538 within 5 minutes

Clostridium sporogenes ATCC Three-log reduction

11437 within 5 minutes

Candida albicans ATCC 10231 Three-log reduction

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

within 5 minutes

Aspergillus niger ATCC 16404 Three-log reduction

within 5 minutes

Environmental isolates from wall Three-log reduction

(micrococcus lutes) within 5 minutes

Environmental isolates from Three-log reduction

operator’s fingerprint (Bacillus within 5 minutes
spp.)

Environmental isolates from floor Three-log reduction

(Aspergillus) within 5 minutes

Environmental isolates from glass Three-log reduction

window (Staphylococcus within 5 minutes
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (E)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Glass Windows (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction

ATTCC 9027 within 5 minutes

Escherichia coli ATCC 8739 Three-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction

within 5 minutes

Staphylococcus aureus ATCC Three-log reduction

6538 within 5 minutes

Clostridium sporogenes ATCC Three-log reduction

11437 within 5 minutes

Candida albicans ATCC 10231 Three-log reduction

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

within 5 minutes

Aspergillus niger ATCC 16404 Three-log reduction

within 5 minutes

Environmental isolates from wall Three-log reduction

(micrococcus lutes) within 5 minutes

Environmental isolates from Three-log reduction

operator’s fingerprint (Bacillus within 5 minutes
spp.)

Environmental isolates from floor Three-log reduction

(Aspergillus) within 5 minutes

Environmental isolates from glass Three-log reduction

window (Staphylococcus within 5 minutes
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (F)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Concrete Walls Finished with Antifungal Oil Paint (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction

ATTCC 9027 within 5 minutes

Escherichia coli ATCC 8739 Three-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction

within 5 minutes

Staphylococcus aureus ATCC Three-log reduction

6538 within 5 minutes

Clostridium sporogenes ATCC Three-log reduction

11437 within 5 minutes

Candida albicans ATCC 10231 Three-log reduction

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

within 5 minutes

Aspergillus niger ATCC 16404 Three-log reduction

within 5 minutes

Environmental isolates from wall Three-log reduction

(micrococcus lutes) within 5 minutes

Environmental isolates from Three-log reduction

operator’s fingerprint (Bacillus within 5 minutes
spp.)

Environmental isolates from floor Three-log reduction

(Aspergillus) within 5 minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (G)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Floor (Epoxy) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within 5

ATTCC 9027 minutes

Escherichia coli ATCC 8739 Three-log reduction within 5

minutes

Bacillus subtilis ATCC 6633 Three-log reduction within 5

minutes

Staphylococcus aureus ATCC Three-log reduction within 5

6538 minutes

Clostridium sporogenes ATCC Three-log reduction within 5

11437 minutes

Candida albicans ATCC 10231 Three-log reduction within 5

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

minutes

Aspergillus niger ATCC 16404 Three-log reduction within 5

minutes

Environmental isolates from wall Three-log reduction within 5

(micrococcus lutes) minutes

Environmental isolates from Three-log reduction within 5

operator’s fingerprint (Bacillus minutes
spp.)

Environmental isolates from floor Three-log reduction within 5

(Aspergillus) minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (H)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Machines (Product Contact Stainless Steel 316) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within

ATTCC 9027 5 minutes

Escherichia coli ATCC 8739 Three-log reduction within

5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction within

5 minutes

Staphylococcus aureus ATCC Three-log reduction within

6538 5 minutes

Clostridium sporogenes ATCC Three-log reduction within

11437 5 minutes

Candida albicans ATCC 10231 Three-log reduction within

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

5 minutes

Aspergillus niger ATCC 16404 Three-log reduction within

5 minutes

Environmental isolates from wall Three-log reduction within

(micrococcus lutes) 5 minutes

Environmental isolates from Three-log reduction within

operator’s fingerprint (Bacillus 5 minutes
spp.)

Environmental isolates from floor Three-log reduction within

(Aspergillus) 5 minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (I)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Manufacturing Vessels (Non-Product-Contact Stainless Steel 304)

(Coupons)
Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within 5

ATTCC 9027 minutes

Escherichia coli ATCC 8739 Three-log reduction within 5

minutes

Bacillus subtilis ATCC 6633 Three-log reduction within 5

minutes

Staphylococcus aureus ATCC Three-log reduction within 5

6538 minutes

Clostridium sporogenes ATCC Three-log reduction within 5

11437 minutes
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Candida albicans ATCC 10231 Three-log reduction within 5

minutes

Aspergillus niger ATCC 16404 Three-log reduction within 5

minutes

Environmental isolates from wall Three-log reduction within 5

(micrococcus lutes) minutes

Environmental isolates from Three-log reduction within 5

operator’s fingerprint (Bacillus minutes
spp.)

Environmental isolates from floor Three-log reduction within 5

(Aspergillus) minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment No. 1700.140(J)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Washing Basin (Stainless Steel 304) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within 5

ATTCC 9027 minutes

Escherichia coli ATCC 8739 Three-log reduction within 5

minutes

Bacillus subtilis ATCC 6633 Three-log reduction within 5

minutes

Staphylococcus aureus ATCC Three-log reduction within 5

6538 minutes

Clostridium sporogenes ATCC Three-log reduction within 5

11437 minutes

Candida albicans ATCC 10231 Three-log reduction within 5

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

minutes

Aspergillus niger ATCC 16404 Three-log reduction within 5

minutes

Environmental isolates from wall Three-log reduction within 5

(micrococcus lutes) minutes

Environmental isolates from Three-log reduction within 5

operator’s fingerprint (Bacillus minutes
spp.)

Environmental isolates from floor Three-log reduction within 5

(Aspergillus) minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment No. 1700.140(K)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Bench (Stainless Steel 304) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within 5

ATTCC 9027 minutes

Escherichia coli ATCC 8739 Three-log reduction within 5

minutes

Bacillus subtilis ATCC 6633 Three-log reduction within 5

minutes

Staphylococcus aureus ATCC Three-log reduction within 5

6538 minutes

Clostridium sporogenes ATCC Three-log reduction within 5

11437 minutes

Candida albicans ATCC 10231 Three-log reduction within 5

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

minutes

Aspergillus niger ATCC 16404 Three-log reduction within 5

minutes

Environmental isolates from wall Three-log reduction within 5

(micrococcus lutes) minutes

Environmental isolates from Three-log reduction within 5

operator’s fingerprint (Bacillus minutes
spp.)

Environmental isolates from floor Three-log reduction within 5

(Aspergillus) minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (L)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Tables (Stainless Steel 304) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction

ATTCC 9027 within 5 minutes

Escherichia coli ATCC 8739 Three-log reduction

within 5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction

within 5 minutes

Staphylococcus aureus ATCC Three-log reduction

6538 within 5 minutes

Clostridium sporogenes ATCC Three-log reduction

11437 within 5 minutes

Candida albicans ATCC 10231 Three-log reduction

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

within 5 minutes

Aspergillus niger ATCC 16404 Three-log reduction

within 5 minutes

Environmental isolates from wall Three-log reduction

(micrococcus lutes) within 5 minutes

Environmental isolates from Three-log reduction

operator’s fingerprint (Bacillus within 5 minutes
spp.)

Environmental isolates from floor Three-log reduction

(Aspergillus) within 5 minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________

 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Attachment (M)

DISINFECTANT VALIDATION RESULTS

Disinfectant: ______________________ _________________Lot No.:

Supplier: _________________________________________________

Analyzed on:(provide date) Analyzed by: (provide

name)

Tested for: Disinfectant Efficacy

The test has been carried out at the predetermined concentration of

manufacturer (_____%)

Efficacy Test on Doors/Lockers (Melamin) (Coupons)

Organism Acceptance Criteria Result

Pseudomonas aeruginosa Three-log reduction within

ATTCC 9027 5 minutes

Escherichia coli ATCC 8739 Three-log reduction within

5 minutes

Bacillus subtilis ATCC 6633 Three-log reduction within

5 minutes

Staphylococcus aureus ATCC Three-log reduction within

6538 5 minutes

Clostridium sporogenes ATCC Three-log reduction within

11437 5 minutes
 Humanwell Pharmaceutical Ethiopia PLC
Form No.: SOP/SL/003/F/01
Disinfectants Validation Report Form

Candida albicans ATCC 10231 Three-log reduction within

5 minutes

Aspergillus niger ATCC 16404 Three-log reduction within

5 minutes

Environmental isolates from wall Three-log reduction within

(micrococcus lutes) 5 minutes

Environmental isolates from Three-log reduction within

operator’s fingerprint (Bacillus 5 minutes
spp.)

Environmental isolates from floor Three-log reduction within

(Aspergillus) 5 minutes

Environmental isolates from glass Three-log reduction

within 5 minutes
window (Staphylococcus
epidermis)

Analyzed by: Microbiologist Checked by: QC Manager

Signature/date: _____________________ Signature/date: ___________________