Pfizer Controlled Document Document Signatures:: Signature Date/Time (GMT) Signature Reason

Status Effective Effective Date 08-Feb-2018 Version 2.
0 Doc Name MCD-075928

GENERAL SPECIFICATION FOR CARTONS, TRAYS AND SLEEVES
Title
Doc Alias QO-00-B223-01 Site Code / Department mcd / Vizag
Pfizer Controlled Document
Document Signatures:
Signature Date/Time (GMT) Signature Reason
K,PRAVEEN KUMAR 08-Feb-2018 10:19:55 Departmental Approval
Pothireddy,Venkatreddy 08-Feb-2018 10:32:04 Quality Approval
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Access Date: 08-Feb-2018 14:28:18 GMT
Viewed On: 30-Jul-2019 05:41:51, GMT -04:00
Status Effective Effective Date 08-Feb-2018 Version 2.0 Doc Name MCD-075928
Title

FOR PFIZER INTERNAL USE ONLY
PFIZER QUALITY ACCEPTANCE CRITERIA

GLOBAL OTHER MATERIAL
SUPPLY
DOCUMENT NO.: QO-00-B223-01
SOURCE DOCUMENT(S) AND DATE(S): QO-00-B223-00 (09-NOV-2017)
MATERIAL NAME: GENERAL SPECIFICATION FOR CARTONS, TRAYS
AND SLEEVES
DOCUMENT NO.: DESCRIPTION OF CHANGES

1. Reference to “individual specification” mentioned in acceptance crieteria
of dimensional evaluation.
QO-00-B223-01 2. Retest period and Tests to be carried out during retest period included.
Change Record Number(s): PR# 2106917
HISTORY OF CHANGES
DOCUMENT
DOCUMENT NO.: DESCRIPTION OF CHANGES
APPROVAL DATE
New General Specification for Cartons, Trays and
Sleeves
QO-00-B223-00 09-NOV-2017
Change Record Number(s): PR#1999787
Legacy Document Number(s): ORIGINAL
Associated Regulatory Specification(s): N/A
Notes: N/A
PFIZER CONFIDENTIAL
PQS M3106 FORM QO_V8(5-16)
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Title

NOT FOR REGULATORY FILING

SUPPLY
AND SLEEVES
TEST NAME TEST METHOD ACCEPTANCE CRITERIA

NOTE: For cartons and trays, at least one sample from each
cutting die position should be evaluated.
A. CL (AQL): CL 9 (1.5)
Dimensions must be as specified.
See Note:
NOTE: Dimensionally check a minimum of one sample from
each die position for length, width and depth and other
As per STP dimensions (affected by die cutting) indicated by a control level
symbol.
mentioned in
Dimensions (Refer individual Specification under physical characterstics).
individual B. CL (AQL): CL 9 (1.5)
specification Board thickness must be
+ or - 0.001 inch (0.024 inch or less)
+ or - 0.002 inch (greater than 0.024 inch)
NOTE: Board thickness may be + 0.003 inch - 0.001 inch for
items that are manually set up. Items destined for machine set
up and product loading must have board tolerances as specified
in "B" above. (i.e. syringe cartons, Palmer trays, kit and combo
cartons, individual ampoule cartons and PTK carton all must be
as specified in "B" above).
A. Material(s) must be as specified.
B. CL (AQL): CL 8 (0.65)
Scorelines must be visible through entire length of scores.
C. CL (AQL): CL 1 (no defects allowed)
For Flat Blank Tray
As per STP Grain Direction : Grain direction should be perpendicular
Visual and
mentioned in to dust flaps / Glue flaps (Refer below Drawing).
functional
individual D. CL (AQL): CL 1 (no defects allowed)
Evaluation
specification 1.Copy must be identical to approved copy proofs supplied
by Hospira. Reference marks must appear per approved
copy. Artwork and negatives supersede specified drawing
for reference marks and baseline placement. However,
due to die cutting variation the reference marks may, also,
appear on the opposite side of the carton.
PFIZER CONFIDENTIAL
Viewed On: 30-Jul-2019 05:41:51, GMT -04:00
Title


SUPPLY
AND SLEEVES

E. CL (AQL): CL 7 (0.40)
Printing must be legible
F. CL (AQL): CL 7 (0.40)
Pre-applied hot melt (where applicable) must be present and
positioned as indicated on drawing.
G. CL (AQL): CL 7 (0.40)
Special score and glue configuration(s) (such as automatic
bottoms, outfold or infold trays, center supports, partitions,
dividers, etc.) must function as intended and must exhibit good
workmanship. (where applicable)
H. CL (AQL): CL 7 (0.40)
Manufacturer's glue joint and all other glue points (such as
partitions, glued bottoms) must be glued securely, and when
pulled apart, must evidence fiber tear. (where applicable)
I. CL (AQL): CL 8 (0.65)
Color(s) must be as specified.
J. CL (AQL): CL 8 (0.65)
Preglued cartons must be set up correctly, squarely, without
distorting gluing on corners and evidence good workmanship.
(where applicable)
K. CL (AQL): CL 9 (1.5)
Areas to be unvarnished:
1. Lot Number and Expiration Date areas when designated.
2. Major flap surfaces for cartons designed for glue sealing.
PFIZER CONFIDENTIAL
Viewed On: 30-Jul-2019 05:41:51, GMT -04:00
Title


SUPPLY
AND SLEEVES

L. CL (AQL): CL 10 (2.5)
Samples must be free from smudges, scuffs, grease and oil
spots on either surface, and free from tears, shreds, chaff,
or debris.
M. CL (AQL): CL 10 (2.5)
Opening and dispensing features of the carton (including
perforated flaps) must function adequately to provide the
user easy access to the product during use (where
applicable).
N. CL (AQL): CL 11 (4.0)
Printing must be of good quality and exhibit good
workmanship.
Retest period: 3 Years.

Tests to be carried out during Retest period: Visual and Functional Evaluation (As applicable).
Cross Direction
Grain Direction
PFIZER CONFIDENTIAL
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Status Effective Effective Date 08-Feb-2018 Version 2.

0 Doc Name MCD-075928

Doc Alias QO-00-B223-01 Site Code / Department mcd / Vizag