MANUFACTURING INSTRUCTIONS

TITLE: To prepare N410 RE Formulation – Trail 1 Page 1 of 6

Document No: MI-XP10090
Revision: Rev 0

DOCUMENT ISSUANCE RECORD

Document issued by:
Batch No: XP-120915-1

Signature Date Mfg Date: Sep 12, 2015

Document received by:
Exp Date:

Signature Date Issue No.:

YIELD:
Theoretical Batch size:

Actual Batch size:

% Yield:

MANUFACTURING CHEMIST APPROVAL

Commenced On: Completed On:

Signature Date Signature Date

FINAL APPROVAL RECORD:

Signature Date

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.
 MANUFACTURING INSTRUCTIONS
TITLE: To prepare N410 RE Formulation – Trail 1 Page 2 of 6
Document No: MI-XP10090
Revision: Rev 0

1. SCOPE:

This document contains instruction for the preparing N410 RE Formulation – Trial 1 solution

2. SUPPORTING DOCUMENTATION:

None

3. SIGNATURE RECORD:

Any one whose initials and / or signature lie within this document must enter his/her printed
name, signature and initials.

PRINTED NAME SIGNATURE INITIALS

K.Vijaya lakshmi

N.Vijaya Swathi

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.
 MANUFACTURING INSTRUCTIONS
TITLE: To prepare N410 RE Formulation – Trail 1 Page 3 of 6
Document No: MI-XP10090
Revision: Rev 0

4. EQUIPMENT AND MATERIALS:

4.1 EQUIPMENT

No Major Equipment needed

4.2 INVENTORY CONTROL / DISPENSING SHEET

Ingredient Specifica ID Quantity Quantity Received

tion (Batch / required Removed By
Lot No.)
B. alcalophilus

B. amyloliquefaciens

B. subtilis

B. atrophaeus

B. megaterium

B. pumilus

B. licheniformis

PEG 6K

Xanthum Gum

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.
 MANUFACTURING INSTRUCTIONS
TITLE: To prepare N410 RE Formulation – Trail 1 Page 4 of 6
Document No: MI-XP10090
Revision: Rev 0

4.3 LINE CLEARANCE

None

5. GENERAL INSTRUCTION

5.1 CLOTHING

1. Operators should wear a clean lab coat, head cover and gloves through out the
whole Packing operation.

5.2 WORK SPACE

1. The workspace should be clean and free of any materials or equipment that is
not called out in this manufacturing instruction.

5.3 EQUIPMENT

All necessary equipment that has been referenced in equipment list should be checked to ensure
that the proper equipment is on hand, that the equipment logs (where applicable) are complete and
up to date, and that the equipment bears stickers that show that each is with its calibration date
(where applicable)

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.
 MANUFACTURING INSTRUCTIONS
TITLE: To prepare N410 RE Formulation – Trail 1 Page 5 of 6
Document No: MI-XP10090
Revision: Rev 0

Preparation of N410 RE solution – Trial 1

No INSTRUCTION Performed
By/Date
1 Take 100200ml sterile glass bottle
2 Add 12.15mL of B.alcalphilus stock solution prepares as per MI XP100___ and
record in Attachment 1
3 Add 12.15mL of B. amyloliquefaciens stock solution prepares as per MI
XP100___ and record in Attachment 1
4 Add 7.48mL of B. subtilis stock solution prepares as per MI XP100___ and
record in Attachment 1
5 Add 7.48mL of B. atrophaeus stock solution prepares as per MI XP100___
and record in Attachment 1
6 Add 28.04mL of B. megaterium stock solution prepares as per MI XP100___
and record in Attachment 1
7 Add 28.36mL of B. pumilus stock solution prepares as per MI XP100___ and
record in Attachment 1
8 Add 9.35mL of B. licheniformis stock solution prepares as per MI XP100___
and record in Attachment 1
9 Add 2gm of PEG6K and stir solution to dissolve. Record in attachment 1
10 Add 2gm of XG and stir solution to dissolve. Record in attachment 1
11 Record pH. Adjust pH with organic acid or NaOG as needed to bring it to 3.0.
Record in attachment 1.
12 Close cap, label and store solution

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.
 MANUFACTURING INSTRUCTIONS
TITLE: To prepare N410 RE Formulation – Trail 1 Page 6 of 6
Document No: MI-XP10090
Revision: Rev 0

Attachment # 1

Preparation of N410 RE solution – Trial 1

Date: Performed By:

No Ingredients Lot ID Time Wt/Vol

added

1 B. alcalophilus
2 B. amyloliquefaciens
3 B. subtilis
4 B. atrophaeus
5 B. megaterium
6 B. pumilus
7 B. licheniformis
8 PEG 6K
9 Xanthum Gum

Initial pH Final pH:

This is a confidential document owned by KN Biosciences. Reproduction of this document in any form is not permitted without the
prior written permission KN Biosciences.