B-910
Weighing and Dispensing Procedure
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1.0 Purpose
The purpose of this procedure is to establish a process for the weighing and dispensing of powder
and liquid raw materials.
2.0 Seope
This procedure applies to the weighing and dispensing of powder and liquid raw materials at lon
Labs, inc.
Responsibility
3 nc
It is the responsibility of all personnel involved in the weighing and dispensing of powder
and liquid raw materials to follow this procedure.
3.2 ‘It is the responsibility of the Department Manager/Supervisor to implement this procedure
and to ensure that all involved personnel are adequately trained.
oG )nw It is the responsibility of QC to inspect and ensure that this procedure is followed.
4.0 Definitions
4.1 Weighing -The process of grouping appropriate amounts of necessary materials used ina
specific stage of a manufacturing process
4.2 Dispense At Site (DAS) — The process of weighing / dispensing a specified quantity during
the manufacturing operation rather than at the weighing / dispensing process
4.3 BPR — Batch Production Record
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4.4 OC — Quality Control
R Namber — Receiving Number; a unique identifying number assigned to raw materials
upon receipt
RMD Number — Raw Material Identification Number
4.7 FIFO — First In, First Out; an inventory plan that ensures that items purchased first will be
used first. Raw materials, components, drug related products, containers, and closures
approved for use shall be rotated so that the oldest approved stock is used first. Deviation
from this requirement is permitted if such deviation is temporary and appropriate.
4.8 Issuance — The process of identifying materials in inventory and selectively placing them
as used in a batch
4.9 ERP ~ Enterprise Resource Planning
4.10 PPE - Personal Protective Equipment
4.1] LPN -- License Plate Number; A unique identifier in for a given handling unit, commonly
a pallet, that is used to track that handling unit throughout its lifecycle
5.0 References
5.1 A-108, SOP, Good Manufacturing Practices and Personal Hygiene
QS-106, SOP, Allergen Control
A-107, SOP, Workplace Safety Procedure
5.4 F-53510, SOP, Sharp Instrument Control Procedure
5.5 C-201, SOP, Deviation and Investigation Procedure
B-111, SOP, Cleaning of Manufacturing/Production Areas and Equipment
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Standard Operating Procedure SOP No | Rev No | page
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Weiching and Dispensing Procedure
B-103, SOP, Small Parts Cleaning and General Sanitation
B-901, SOP, Blending Procedure -- Powders
B-908, SOP, Blending Procedure - Liquids
G-207, SOP, Calibration Verification and Operation of Scales
5.11 E-901, SOP, Shipping and Receiving Transport Inspection
Weigh Staging
6.1 Before staging begins, generate and gather the following documents for the batch for the
weighing/dispensing process.
6.1.1 A picklist of the batch
6.1.2 The batch record for the batch
Note: Materials must be picked and allocated in FIFO order unless justification can be
provided.
Weighing personnel will confirm that all materials are in Released status or in an At Risk
status.
Weighing personnel will designate and label an area with the batch number of the finished
product and the stage they are staging.
6.4 Before moving any material into the weighing room, the operator and OC imspector must
check the following on the raw material container:
6.4.1 Check the material RMID number against the BPR.
6.4.2 Check the description of material against the BPR, and the supplier container tag.
6.4.3 Document the verification that the materials are accurate (RMID number, R
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number, and description of the material with a signature and date in the BPR from
a weighing operator and QC).
Note: H'the material description or RMID number does not match those listed in the BPR,
contact QC and Production Management. QC will place a hold tag on the material
in question and isolate it from the remaining raw materials. Do not proceed until
QC or Production Management indicates that it is acceptable to proceed.
6.4.4 Check the R numbers and quantities outlined on the pick fist provided against what
is physically located inside the weighing room. This information must. be
consistent.
7O Weighing
7d General Requirements for Weighing rooms
FLA Personnel and visitors must follow good manufacturing practices as per SOP A-
108 Good Manufacturing Practices and Personal Hygiene. Personne! must follow
safety precautions by wearing appropriate PPE as outlined in SOP A-107
Workplace Safety Procedure.
Personnel must wear company frocks and/or lab coats, hairnets, shoe covers and/or
dedicated shoes (as applicable), beard covers (if applicable), dust masks, gloves,
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and safety glasses.
Operators must use stainless steel scoops or disposable scoops for the weighing of
raw materials.
7.13.1 If using stainless steel scoops, the scoops must be cleaned between the
weighing of raw materials and transported from the wash area to the weigh
room ina clean and sanitized container or bag. Once returnetdo the weigh
room, the scoops must be sanitized with IPA and allowed to dry prior to
being used.
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7.1.3.2 For materials containing an allergen, yellow scoops must be used.
Allergen scoops shall be cleaned between the weighing of allergen
materials and transported from ihe wash area to the weigh room ina clean
and sanitized container or bag. Once returned to the weigh room, the
scoops niust be sanitized with IPA and allowed to dry priotro being used.
7.1.3.3 Ifusing disposable scoops, the scoops must be discarded after each raw
material type has been weighed. Disposable scoops cannot be used to
weigh more than one type of raw material. It is acceptable to use the same
scoop when weighing different lots of the same raw material.
7.1.4 When weighing materials that require cold storage pull the materials from the
cooler only at the time of weighing and immediately place material back in cooler
after weighing. Material weighed for the batch will need to be placed in a portable
cooler for transportation and marked with a ‘keep refrigerated sticker’. The items
that require cold storage need to be specifiebdy the weighing operator on the weigh
and mix page in the batch record,
7.1.5 Operators must use approved blades to preform job duties as referenced in SOP F-
510 Sharp Instrument Control Procedure.
Note: Gloves must be changed and discarded or sanitized after the weighing process of
each raw material,
7.2 Complete room clearance before bringing any materials into the room by meeting the
following requirements:
7.2.1 Ensure that the weighing room and utensils are clean and the cleaning has been
properly documented as outlined in SOP B-lil Cleaning of
Manufacturing/Production Areas and Equipment.
7.2.2 Ensure that a daily scale performance check is complete and documented as
outlined in SOP G-207 Calibration Verification and Operation ofScales.
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72.3 Check the scale calibration sticker to ensure that the scale calibration has not
expired. Report expired calibration to QC personnel. De not use equipment with an
expired calibration.
794 Check the calibration status of any other equipment required by the BPR. For
example, if a hygrometer is required by the BPR to record humidity levels, ensure
that the hygrometer calibration is not expired.
7.2.5 Identify the weighing room with the correct product detail tag.
796 Document the verification of room clearance with a signature/date in the BPR from
a weighing operator and QC.
7.3 Allergen Controls
7.3.1 Wfallergenic materials are included for this stage of the batch, adhere to the items
in the “Allergen Controls” section.
oh
7.3.2 Remove all non-allergenic materials from the weighing room. This mecludes
allergenic materials that are not in the same class as this allergenic material.
7.3.3. Ensure proper utensils are used and frocks/lab coats are worn during the
handling/processing of any allergen materials as defined in SOP A-108 Good
Manufacturing Practices and Personal Hygiene and Q5-106 Allergen Control to
eliminate any chance for cross contamination. Frocks and lab coats must be
changed after allergen usage. Ensure a proper clean bas been performed prior to the
start of any weighing of raw materials containing allergens.
74 General Weighing Process
7.4.1 During the weighing process, the following steps should be observed:
7.4.1.1 Set the scale to the unit of measurement (kg or Ib) indicated on the BPR.
741.2 Tare the scale to read zero between cach weighing step.
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7.4.1.3 Document the R number of each raw material in the BPR.
74.1.4 Tf multiple R numbers are used, document each R number and the
individual weight in the amount section of the BPR.
7.4.1.5 All raw materials weighed shall be double bagged with the approved
liners used for weighing.
741.6 Materials that are identified as environmentally unstable outside the
original manufacturing container will need fo be weighed out last and
NMT 48hrs before the kitted batch is sent to production. Raw materials
are identified as light and/or air sensitive on the raw material label that is
affixed to the contamers.
Note: Use FIFO during the weighing process if multiple R numbers are received
from warehouse personnel.
7.4.4.7 The weighing operator will issue each individual lot of material from
inventory i the ERP inventory system.
7.4.1.8 After weighing, the container/bag of material to be returned to inventory
additionally needs to be weighed on the scale and amount verified before
returning materials to the warehouse. The container/bag should be closed
and sealed in a piastic bag (secondary confinement) and then removed
from the room.
7.4.1.9 Returned material should be sealed with yellow tape and a yellow return
tag.
Note: The color yellow signifies a partial container or container that the original
quantity shown has now decreased and been decremented from.
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8.0 Batch Building
8.1. Weighing personnel will designate and label an area with the batch number of the finished
product and assemble weighed and counted materials for the batch into this area.
8.2 Weighing personnel will create an LPN sticker for each pallet containing the following
information:
8.2.1 Finished product batch number the weighed batch is for
82.2 Product manufacturing stage the batch is for (ic. Powder blending, Liquid
blending, coating)
8.2.3 The pallet number in this batch
8.3 Weighing personnel will generate a manifest, summarizing the following information
about the weighed materials:
8.3.1 Finished product batch number the weighed materiais are for
8.3.2 Product manufacturing stage the weighed niaterials are for (i.e. Powder blending,
Liquid blending, coating}
8.3.3 The total number of containers & weight
8.4 Warehouse management or weighing lead will verify the accuracy of the completed batch
against the manifest generated and the BPR.
8.5 Weig & h ing m personnel will wrap each i p allet to minimize the ossibility of losin S g a) weig & hed
components during transportation and storage.
Note: Each pallet must be wrapped tightly and completely, from bottom to top, and labeled
accordingly with a license plate.
&.6 Quality personnel will verify that completed weighed materials are suitable for transport
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and that all documentation is in order.
8.7 A report of ail materials issued to the batch will be printed and sent with the physical batch.
Lot statuses and expiration dates are quality reviewed at this time.
8.8 Prior io transportation, the weighing lead and a quality personnel will perform a container
count,
8.9 A completed batch will have the following documentation:
8.9.1 A mantfest
8.9.3 LPN stickers on each pallet
9.0 ‘Transportation and Storage of Completed Weighed Batches
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9.2 9.3 ON AC
Completed weighed batches are stored in a Kanban lane along with the associated
documentation generated and collected until time of transportation.
Completed weighed and tightly wrapped batches are transported to the production facility
when the weighed batch is ready for blend.
Company trailers used to transport completed weighed batches will be inspected as
outlined in SOP E-901 Shipping and Receiving Transport Inspection.
A trailer seal will be added to cach shipment of completed weighed batches to ensure
integrity of the batch during transportation to the production facility. The seal number will
be documented during the incoming inspection of the trailer as it arrives at the production
facility.
Prior to blend, blending lead or supervisor verify weighed out materials against the BPR.
and sign off on the verification step.
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10.0 Revision History |
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 09/30/22 | New procedure N/A J. Marphy Changed to disposable scoops. Expanded transportation j 06/15/23 requirements of completed weighed batches. Changed third CC-23-0202 J. Murphy material verification requirement to main facility blender responsibility. Added container count requirements. > HLLD3 Added the option of stainless steel scoops. Added additional CC-23-0553 1. Murphy iformation for scoop control. . oo | - | - |
| 3 | 02/18/25 | Removed process for allocation approval. CC- nap Weighed raw materials need to double bagged, environmentally . nae At . OlN 12O/2 6 unsta&b le mat: erials to be weighed out last = ’ 2 C'&C-L2I66-_O00000!8 J. Murphayr | 25-0076 | J. Murphy |