Document wDObRgJn52EDdk1xg4Lgo1NOB
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Mm PROCESS SPECIFICATION SUBJECT
RESTRICTED
BABY PRODUCTS COMPANY
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7
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MANUFACTURE OF JOHNSON'S BABY POWDER FORMULA 499 AT ESDP
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REV
DATE
DESCRIPTION OF CHANGE
PAGE
1
OF
4
SPEC NO
40116 ORIGINAL DATE
10/1/73
AUTHORIZATION
11/12/76
Specification converted to Baby Products Company format
Sec 7 Fineness revised and Appearance TM 2060 added
BCR 000256
A
6/16/77
Sec 6 revised to conform with Baby Products
Assurance Requirements for Manufacturing
Company
Quality
C
BCR 000620
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RELEASED BY
CATION
.
. Eileen M. Scott
*
FORM 752-11 NEW 1/76
eee
ESDP - Baby .
ISSUE DATE
PRODUCT
6/16/77
30-8
JOHNSON JOHNSON JOHNSON JOHNSON BABY PRODUCTPROSDUCTS COMPANY 1976 J
JNJ 000373977
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,
_
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PROCESS SPECIFICATION
ORIGINAL ISSUE DATE
10/1/73
SUBJECT
REVISION
Johnson
BABY PRODUCTS COMPANY
DATE
PAGE
2
MANUFACTURE OF JOHNSON'S BABY POWDER FORMULA 499 AT ESDP
SPEC NO 40116
DESCRIPTION REQUIREMENTS PROCEDURES
This process specification is to be used in blending of ingredients for Baby Powder
Formula 499 at ESDP
MATERIALS
Perfume Synfleur P
Windsor 66 Talc
R.M. Code
717-258-4
'
712-003-4
Spec No.
04-015 01-011
EQUIPMENT
A. Talc Handling- Bag dumper hopper and screw
- Allis Chalmers talc sifter fitted with 2 sets of screens upper
4 mesh and lower 40 mesh - Talc conveying and distribution system consisting of an air conveyor
and interlocked diverting valves
Distribution B. Perfume
- Perfume system consisting of a perfume reservoir
- Precision metering pump and necessary interlocked valving
and piping
C. Powder Compounding - Nauta blenders having connections talc and perfume - Blender mounted on a hydraulic weight control system ~- The perfume unit has a special head for finely dispersing perfume into the talc
~ Lump breaker
Delivery D. Powder
- Sifter fitted with 2 sets of screens upper are 8 mesh lower are
36 mesh
- Air conveying system for transporting powder to filling line
E. Automatic programming equipment for control of the system
QUANTITATIVE FORMULA - A copy of Operating Log Sheet 52-0173 shall be used to record
the processing of the powder
A. Preblend
.
%w
batch
Perfume Synfleur P Windsor 66 Talc
0.22
2.93
7.50
100.00
-4L-
>
Windsor 66 Talc
.96.85
100.00
3300.00
3407.50 |
B. The following process control points shall be checked for each batch produced
Reference Paragraph 6
FORM 752-15 NEW 4'76
& JOHNSON BABY PRODUCTS COMPANY 1576 JOHNSON
J
JNJ 000373978
PROCESS SPECIFICATION
ORIGINAL ISSUE DATE
10/1/73
SUBJECT
REVISION
A
BABY PRODUCTS COMPANY
DATE
PAGE
6/16/77
3
MANUFACTURE OF JOHNSON'S BABY POWDER FORMULA 499 AT ESDP
SPEC NO 40116
B. Log Sheet Control
Time of each process step - Initials of compounder - Initials of checker - Pertinent data - Material control numbers
atest Print Weight Control ,
- Material identification - Material control number
- Batch identification
- Initials of compounder
- Initialosf checker
:
ee
Tank Identification
- Batch identification
- Batch control number
heathDY
Temperature Control Charts - Chart identification
rev. e
- Temperature characteristics
jog
' Timing and printing
RE 5
,
Ri Sh a 4
Bs
2
OPERATING PROCEDURE
Preblend Add talc through talc delivery system to blender Add perfume to
v4
A. Perfume
-
correct blender With the lump breaker
cylinder running
and position valves inject and disperse
to feed the
the perfume
into the talc the talc for
After the perfume
6 minutes with the
addition lump
has been completed blend the perfume with
breaker running
_
After the 6 minute blending of the preblend perfume perfume mixture turn the
B. Talc Delivery -
to start and add talc The system will shut down automatically automatically
talc delivery switch
blender full light will come on followed followed
when the correct amount has been added
The
mix
Following Quality Control acceptance
by a blender ready light after a 10 minute
of the batch the blender release light must be activated
- C.
Powder
Delivery
After
the
batch
is
released
it
is transferred
by
an
air conveying
level
to the vacuum powder filler surge hopper as demanded by the surge hopper
system
delivered unless the blender release light has been
controls No powder can be
: activated 6. BABY PRODUCTS COMPANY QUALITY ASSURANCE REQUIREMENTS FOR MANUFACTURING
Shall comply with JOHNSON & JOHNSON Baby Manufacturing Operations B.P.P. 27-01
Products
Company
Minimum
Requirements
for
FORM 752-15 NEW 4/76
JOHNSON & JOHNSON BABY PRODUCTS COMPANY 1979
JNJ 000373979
Johnson
BABY PRODUCTS COMPANY
PROCESS SPECIFICATION
ORIGINAL ISSUE DATE
.
10/1/73
REVISION
DATE
Pace
A
6/16/77
4
m
SUBJECT
MANUFACTUROEF JOHNSON'S BABY POWDER FORMULA 499 ESDP
SPEC NO
7. FINISHED MATERIAL PROPERTIES & REQUIREMENTS
Water Soluble Color TM 1346
.....
No more with no
than blue
a very pale greenish or
or other color visible
gray
white
Fineness
TM
-1231
.
....++-s+eeeees
ac eee ee ne ees ...
cece eee eeeoeees
;
98.5 minimum through 200 99.7 minimum through 100
99.98 minimum through 60
mesh mesh mesh
sieve sieve sieve
Odor
Characteristic perfume as compared to a reference
TM 206 ees 1 e eens..
standard
Foreign Matter TM 2060
.....-6---
Free of dirt and foreign through the powder shall
particles
matter show no
A magnet drawn
evidence of metal
Appearance
TM 2060
...cssceceeees
Free of dirt
of tlc
foreign matter
grittiness and clumps
be
.
+
eo
Bp
A
:
po
Lo
e
fo ! i
u
Re FORM 752-15 NEW 4/76
JOHNSON 4 JOHNSON
JOHNSON BABY PRODUCTS COMPANY COMPANY 1976
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JNJ 000373980