HMA MEDICAL LIMITED

Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.

DEVICE HISTORY RECORD

DEVICE HISTORY RECORD (DHR)

FOR

DELEJECT 5ML HYPODERMIC NEEDLE

AND

SYRINGE

Table of content Page

Index 1
1.0 Product Description 2
2.0 Summary of Manufacturing Process 2
3.0 Bill of Materials 3
3.1 Raw material requisition manufacturing work order 3
4.0 Brief description of operations 4
4.1 Component Preparation 4
4.2 Dispensing 4
4.3 Line Clearance 4
4.4 Moulding Section 5
 HMA MEDICAL LIMITED Page 1 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

4.5 Preparation and Graduation of Barrel 6

4.6 Syringe Assembly 7
4.7 Blistering of Assembly Needle and Syringe 8
5.0 Production Flow Chart 9
6.0 Quality Assurance Procedure 10
6.1 In-process Quality Control in Injection Moulding 10
6.2 In-process Quality Control in Printing & Syringe Assembly 11
6.3 Blister Packing section in process check report 12
7.0 Packaging Procedures 13
7.1 Quality Assurance Authorization to pack 13
7.2 Issuance of packaging material 13
7.3 Line clearance 13
7.4 Packaging 14
8.0 Labelling procedures 15
8.1 Inner and Shipper Cartons coding 15
9.0 Sterilization procedure 15
9.1 Line Clearance 15
9.2 Terminal sterilization by Ethylene Oxide Gas 16
121 10.0 Final Batch Reconciliation 17
11.0 Post sterilization inspection and testing 17
11.1 Intimate Quality Control of completion and sampling 17
11.2 Sampling details 17
12.0 Inspection and release procedures 17
12.1 Deviation Approval Sheet 18
12.2 Certification of batch release 18

THIS DOCUMENT AUTHORIZES THE FOLLOWING DEVICE HISTORY RECORD FOR THE MANUFACTURE
OF DELEJECT 5ML HYPODERMIC SYRINGE & NEEDLE

1.0 PRODUCT DESCRIPTION

Product Details
A. Description DELEJECT BLISTERED 5ML HYPODERMIC SYRINGE & NEEDLE 21G X 11/2’’
UNIQUE ID NO: DHR. NO: DHR REV. NO.& DATE
QUANTITY OF DEVICE Mfg. Date MDR REV. NO. & DATE
MANUFACTURED:
Expiry Date REF. MDR NO.
 HMA MEDICAL LIMITED Page 2 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

i. Product Size 5ML Pack size syringe with 21G X 11/2’’ needle
ii. Packaging Each pack contains: A single use 5ML syringe & (21G X 11/2’’) Needle pair
Description Pack Size: Blister Packing of 10 blisters of 10 pair of (needle and syringe) each, packed in printed inner cartons.
Carton Packing: 24 inner cartons in a corrugated shipper carton.

1.0 SUMMARY OF MANUFACTURING PROCESS

Storage Condition: Store in a cool dry place, and free from direct sunlight
Document Issued By QA: Date: Document Received By: Date
This Document Supersedes:
Raw Weighing, Injection Barrel Syringe Needle Blistering Packaging Sterilization
Materia Crushing Molding Printing Assembly Assembly
ls &Mixing
Unique I.D. No.
Date of Commencement/MFD

Date of Completion/EPD
Qty. Of Components
Produced (pcs)
Qty. of Re-run Generated kg
(pcs)
Qty. of Waste Generated kg
(pcs)
Checked By Shift Executive: Date: Time:
This batch has/has not been completed according to the instructions given in DMR No. …../………../00.
Deviation attached Yes/No

Actual Yield……………Pcs. Theoretical Yield……………………(Pcs) of Blistered Syringe. Qty of Re-run Generated………………….kg(pcs)

Qty of Waste generated…………………………………….kg (pcs) . Total Yield……………………………………%

Final DHR Checked By Date Final DHR Verified By Date
Prepared By Checked By: Production. Mgr. Reviewed By: Qc Manager Approved By QA Mgr.
Prodn.Exec.

Date Date Date Date

FORMAT & DOCUMENT:

PREPARED BY: PRODUCTION IN-CHARGE SIGN & DATE:

CHECKED BY: PRODUCTION MANAGER SIGN & DATE:

APPROVED BY: QUALITY CONTROL MANAGER SIGN & DATE:

AUTHORIZED BY: QUALITY ASSURANCE MANAGER SIGN & DATE:

This batch has been manufactured according to the Device Master Record No. HMA/PR/DMR/SY-00 without any
modification /with following modifications:
 HMA MEDICAL LIMITED Page 3 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

3.0 BILL OF MATERIAL

3 .1 RAW MATERIALS REQUISITION-MANUFACTURING WORK ORDER FOR 5ML HYPODERMIC SYRINGE WITH 21G X 11/2’’NEEDLE
Sr. UOM Std. Qty. AR. No. Gross Tare Net Issued by Checked by Prod Verified
No Unique ID. NO. weight weight weight Stores
Raw Material(s)
Barrel 5ml
1 Polypropylene Kg 615.92
Plunger
1 Polyethylene Kg 521.16
Hub
1 Polypropylene Kg 50.76
2 Colour Master Batch Kg 0.03
Needle Caps
1 Polypropylene Kg 196.28
Assembled Needle
1 Assembled Needle pcs 331,780
Graduation
1 Ink Kg 0.85
2 Toluene Kg 1.18
3 Silicone Oil (B) Kg 1.880
Blister Packing
1 Dialyzing Kg 117.43
2 PVC Film Kg 127.92
 HMA MEDICAL LIMITED Page 4 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

4.0 BRIEF DESCRIPTION OF OPERATION

4.1 COMPONENT PREPARATION
4.1.1 Barrel, Cap and Hub
Barrels, Caps and Hubs were molded wholly from virgin or a mixture of rerun and virgin polypropylene which shall be suitable
as pharmaceutical/medical grade, non-bleaching and non-toxic. Polypropylene was obtained from approved vendors and meets
material specifications as stated by current version of British Pharmacopeia 2022 and NIS 2020 only and molded as per SOP
No. HMA/PRD/SOP005-03 and shall meet all specifications as stated in these references. The production process involve
wherein molten plastic is injected into a mold cavity, imparting the syringe with its desired shape, precision moulding to form
the barrel, plunger, and other components, ensuring each part meets exact size and shape specifications for optimal performance .
This method facilitates efficient mass production of syringes while maintaining consistent dimensions and high accuracy. In-
process checks were undertaken to short out defected parts before embarking on bulk production.
4.1.2 Plunger
Plungers were molded wholly from virgin or a mixture of rerun and virgin polyethylene which shall be suitable for
pharmaceutical grade, non-bleaching and non-toxic. Polyethylene was obtained from approved vendors meets material
specifications as stated by British Pharmacopeia 2022 and NIS 2020 only and molded as per SOP No. HMA/PRD/SOP005-03
and shall meet all specification as stated in these references. . In-process checks were undertaken to short out defected parts
before embarking on bulk production.
4.2 DISPENSING
 Manufacturing was carried out as per the requirement of the current GMP
 Followed personal hygiene requirements
 General cleaning of equipment, machines, utensils, and Weighing Balance calibration as per line clearance SOP
No. HMA/PRD/SOP004-03 was ensured.
 Batch size was made based on requirement. Prior clearance obtained from QA before commencement of work..
 All ingredients have been tested and released by the QC before use as per line clearance SOP No.
HMA/PRD/SOP004-03
 All rejected materials and runners were treated as per line clearance SOP No. HMA/PRD/SOP004-03
 Gowning of personnel was observed as per gowning procedure in SOP HMA/QAD/SOP014-05
 Environmental conditions and balance calibration and equipment were done and properly recorded.
 Dispensing of materials and ingredients were done as per SOP No: HMA/PRD/SOP003-00
 Dispensed materials were transferred to the appropriate production area

UNIQUE ID.NO.
S/No Machinery/Equipment Capacity Previous product Cleaned Checked By Re-checked by
& Batch No On by Prod. exec. QA Officer
1 Weighing Balance
2 Mold & Machine
3 Hopper
4 Feeder
5 Conveyor line
6 Utensils
7 Receiver tray
8 Needle assembly
9 Tools & other accessories
10 Barrel printing Machine
11 Syringe assembly
12 Blistering machine
13 EO gas sterilizing chamber
4.3 Line Clearance Checks as per (SOP No: HMA/PRD/SOP004-03) Date: __________
 HMA MEDICAL LIMITED Page 5 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

4.4 MOLDING SECTION

4.4.1 Carried out Moulding operation and Operated Moulding machines as per: SOP. No: HMA/PRD/SOP005-03.

Previous Product/Batch: UNIQUE ID NO: 4.4.2

Cleaned Checked Verified by MATE
Check List of Actions by (QA Exec.)
On By
Check Area Cleanliness (floor, walls, ceiling).
Check weighing balance, scoops and drums are cleaned
Check the mixer is free from foreign particle and cleaned properly
Check if mold is cleaned
Check if automatic loaders are cleaned & properly fitted
Check if the heating bands and chargers are working properly
Check injection screw if cleaned & properly flushed
Check if the product shooters are cleaned & intact.
Confirm if the chillers are on and working properly.
Check machine settings for compliance with mold technical card
Check and ensure remnant of previous batches have been removed
Check DMR to ensure it is updated properly up till this stage.
Environmental Conditions: DONE BY CHECKED BY
Std. Temp: NMT 28oC Read Temp:
Std. RH: NMT 55% Read RH:

Balance calibration done on date:

RIALS RECONCILLIATION AT INJECTION MOULDING SECTION:

Unique I.D. No.: Barrel Molding Plunger Cap Molding Hub
Molding Molding

Date of Commencement
Date of Completion
Qty. of Virgin Raw Materials used (Kg)
Qty of Re-run added (Kg)
Qty. Of Components Produced (Kg)
Qty. of Re-run Generated (Kg)
Qty. of Waste Generated (Kg)
Percentage Yield
REMARKS:
Done by: Checked by: Verified by:
Production Executive Production Manager QC Manager
Sign & Date: Sign & Date: Sign & Date:

4.5 PREPARATION & GRADUATION OF BARREL

Barrel Printing Machine line was operated as per: SOP. No HMA/PRD/SOP/008-03
1. ……… Kg of the printing ink was weighed and mixed with the solvent toluene in the ratio of 1: 9
2. The mixture of solvent and ink was applied into the printing ink holder on the graduation assembly
3. A trial of the print with 3 to 5 barrels were taken to ascertain the quality of the print on the barrel.
4. The graduation was checked to ensure it corresponds with the delivery volume.
5. The first set of printed barrels were sampled by the Q.C. Officer for volume delivery check, clarity, the graduated lines are
perpendicular to the fiducial line and the zero mark of the graduation line must correspond to the fiducial line.

4.5.1 MATERIALS RECONCILLIATION AT BARREL PRINTING SECTION:

 HMA MEDICAL LIMITED Page 6 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

Unique ID. No: Printed Barrel

Date of Commencement

Date of Completion

Qty. of Blank barrel collected (Kg)

Qty of ink received (Kg)

Qty of silicon mixture received (Kg)

Qty of printed Barrels sampled (Kg)

Qty. of Re-usable waste Generated (Kg)

Qty. of non-reusable Waste Generated (Kg)

Qty of printed Barrels Produced (Kg)

Percentage Yield

REMARKS:

Done by: Production Supervisor Checked by: Production shift in-charge Verified by: QA exec
Sign & Date: Sign & Date Sign & Date

4.6 SYRINGE ASSEMBLY:

Operate Syringe Assembly line as per: SOP. No HMA/PRD/SOP/010-03

4.6.1 Preparation of Silication Mixture

 The silicator unit was checked to ensure it’s free from any blockage.
 ……. litres of silicon B was charge into the silicon feeder tank earlier on diluted in the ratio
1: 3 with the diluent (n-Hexane) and shaken continuously with the aid of mechanical stirrer
for about 1 hour before use.
 The barrel was checked for proper lubrication with a plunger.
4.6.2 Syringe Assembly
 The syringe assembly machine and conveyor lines were Checked to ensure they are cleaned and free from blockades
as per SOP No: HMA/PRD/SOP010-03
 The machine was Switch on and ensured it boots up the computerized machine user interface control.
 The assembly line was set to the appropriate speed.
 A trail run was taken on the assembling unit and checked for the correctness of the output quality and for leaking
barrels, broken barrels, blocked barrels, non-silicated barrels and defective plungers.
 QC was Intimated for sampling of the assembled syringe.
 Full assembly operation was commenced after receiving approval from QC.

Previous Batch Unique ID. No

Check List Checked by (Supervisor) Verified by QA

Area Cleanliness

Equipment & Accessories cleanliness

Absence of previous product/batch materials

Environmental Conditions: Std. Temp: NMT 25oC Temp:

o
C
 HMA MEDICAL LIMITED Page 7 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

Std. RH: NMT 50% RH:

%

4.6.4 MATERIALS RECONCILLIATION AT SYRINGE ASSEMBLY SECTION:

Assembled Syringe
Unique ID No.

Date of Commencement

Date of Completion

Qty. of printed barrel received (Kg)

Qty. of plungers received (Kg)

Qty of silicon mixture received (Kg)
Qty of Assembled syringe sampled (Kg)
Qty. of Re-usable waste Generated (Kg)
Qty. of non-reusable Waste Generated (Kg)
Qty of Assembled syringe Produced (Kg)
Percentage Yield
REMARKS:
Done by: Production Executive Checked by: Production Shift In-charge Verified by: QA Executive
Sign & Date: Sign & Date Sign & Date

4.7 BLISTERING OF ASSEMBLED NEEDLE & SYRINGE

Blistering of Assembled Needle and Syringe was carried out as per: SOP. No HMA/PRD/SOP/013-03

 Required quantities of tested and QA cleared assembled syringes & needles were obtained from Syringe Assembly and
Needle Assembly respectively.
 Checks were carried out to ensure the blistering machine and its conveyor lines are cleaned and free from blockades.
 The machine was switched on to ensure a boot up of the computerized machine user interface control.
 The blistering line was set to the appropriate speed.
 The temperature gauges were checked to ensure the forming mould and sealing mould were appropriately set to the required
temperature.
 Trial run of the blistering operation unit was done to check for the correctness of the output quality in terms of clarity of
batch coding, sealing and batch forming
 The QC was intimated for sampling of the blistered syringe & needle.
 Commenced blistering operation in earnest after receiving approval from the QA.

4.7.1 RECONCILIATION OF MATERIALS AT BLISTERING SECTION:

Syringe Assembled Paper Film
Needle

Unique ID. No

Date of Commencement
 HMA MEDICAL LIMITED Page 8 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

Date of Completion

Qty. Received (Kg)

Qty of materials used (Kg)

Qty. Of Components unused

Qty. of Re-useable Generated (Kg)

Qty. of Waste Generated (Kg)

Qty of blistered products sampled (pcs)

Qty of blistered products Produced (pcs)

Percentage Yield

Done by: Production Executive Checked by: Production Shift In-Charge Verified by: QA Executive

Sign & Date: Sign & Date: Sign & date

5.0 PRODUCTION FLOW CHART FOR SYRINGE & NEEDLE

Material Unloading Process

De-dusting of material in
dedusting area

Raw Material
Packing Material

Under/Test Raw Material Under/Test Packing

QC Check
 HMA MEDICAL LIMITED Page 9 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD
 HMA MEDICAL LIMITED Page 10 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

6.0 QUALITY ASSURANCE PROCEDURES (INSPECTION):

QA performed In-process checks for all manufacturing process as per SOP. No. HMA/QAD/SOP/004-02

6.1 IN-PROCESS CONTROL IN INJECTION MOULDING

Name of parts: Barrel Plunger Cap Hub

Material Used: Polypropylene Polyethylene Polypropylene Polypropylene

Material Lot No:

Unique ID. No

Batch Size

M/C ID:

TEST DESCRIPTION OBSERVATIONS REMARKS

VISUAL TEST BARREL PLUNGER CAP HUB
Appearance
Dust/foreign particles
Pin hole
Blockage
Flash
Short Pieces
Shrinkage
Weird dot, Dent mark
Body Scratch line
Position of Nozzle
Leakage from Gate Point
Leakage from Nozzle
PHYSICAL & FUNCTIONAL TEST
Syringe Nozzle conical Fitting
Deformations test
Lock Test
Air bubble
Weight of component (g)
Length of component (mm)
Dead space (g)
Width (mm)
External diameter (mm)
Wall thickness (mm)
Component Blockage
Colour
Done By: IPQC Sign & Date Checked by QC Executive Sign & Date

Verified By Quality Control Manager: Sign & Date

 HMA MEDICAL LIMITED Page 11 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

6.2 IN-PROCESS CONTROL IN PRINTING & SYRINGE ASSEMBLY UNITS

Date: Print Ink Lot No:

Product: Hexane Lot No:
Operator: Silicon Lot No:
Unique ID. No Toluene Lot No:
Batch Size:
M/C ID: Operator:
TEST DESCRIPTION OBSERVATIONS REMARKS
VISUAL TEST PRINTED BARREL ASSEMBLED SYRINGE
Graduation Lines
Dot, Block marks
Printing Clarity
Single Use only Letters
Assembled Pieces without gaskets
Position of Nozzle
Nozzle Taper
Nozzle Tip
Fiducial Line Positioning
Presence of Foreign particles
Sliding Test
Silicon lubrication
Syringe damage (Barrel + Plunger)
Gate point Leakage
Nozzle point Leakage
ANALYTICAL TEST
Leakage Test:
Actuation force Test
Aspiration Test
DIMENSIONS
VOLUME VERIFICATION
Syringe Size Syringe Maximum Minimum overall length Scale Increment between Maximum Tolerance on
Avg. wt./pc Dead Space of scale to Nominal Interval Graduation lines to Usable Nominal
Capacity be numbered Capacity Capacity

Done By: IPQC Sign & Date

Checked By: QC EXECUTIVE Sign & Date
Verified By: QC MANAGER Sign & Date
 HMA MEDICAL LIMITED Page 12 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

6.3 BLISTER PACKING SECTION IN PROCESS CHECK REPORT

Date: MFD: Printing Ink Lot No
Product: EXP:
Unique ID. No Film Lot No:
Batch Size: Paper Lot No:
Paper Avg, wt./pc: Pack wt.: R/B. Film Avg. wt/pc:
M/C ID No: Operator:
S/No TEST OBSERVATIONS REMARKS
1 VISUAL TEST
2 Pack Sealing
3 Pin hole
4 Batch Printing
5 Foreign Particles
6 Sealing Temperature
7 Damages
8 Blister Leakages
9 DIMENSIONS
1 R/B Film/B.Film.Thickness
2 B,Film/B.paper GSM
3 IC Dimensions/Avg. wt.
4 MC Dimensions/Avg. wt.
Done By: IPQC Sign & Date
Checked By: QC EXECUTIVE Sign & Date
Verified By: QC MANAGER Sign & Date
 HMA MEDICAL LIMITED Page 13 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

7.0 ISSUANCE OF PACKING MATERIALS:

SR.No. Name of the Packing UOM Std.Qty. AR.No. Quantity Issued by: Checked by: Prod. Verified by
Material(s) Issued Store QC

1 Inner carton Nos

2 Corrugated printed Outer Nos

cartons

3 Tape Kg

Issuance Done by Store Officer: Checked by: Packaging Supervisor Verified by: QC Executive
(Sign and Date) (Sign and Date) (Sign and Date)

8.0 LABELLING PROCEDURES

8.1 INNER AND SHIPPER CARTONS CODING
CODING INSTRUCTION: Inner and shipper cartons was coded as per SOP. No. HMA/QAD/SOP/006-04 and
HMA/PRD/SOP21/00

NOTE: Inner and Shipper Carton Coding: First & last coded inner and shipper cartons were checked, approved &
signed by production Manager & Q.C. Manager

9.0 PACKAGING PROCEDURES

9.1 Line Clearance – Packing as per SOP No.: HMA/PRD/SOP004-03

Previous Product Unique ID. No

Check List Done by (Production) Verified by
(Q.C)
Area Cleanliness (Floor, walls, ceiling).
Check the cleanliness of the packing line.
Ensure absence of materials from previous product batch.
Ensure proper batch of product are brought in from assembly line
Ensure all proper materials for packing are available &are as per specification.
Ensure the inner and the outer cartons are properly coded and approved by the Q.C
before packing.

9.2 QUALITY ASSURANCE AUTHORIZATION TO PACK

Blistered Syringe and Needle of Unique ID No…………………………… was manufactured and analysed as per the
standard laid down procedures and specifications and found to comply with specified standards, packing materials
have been analysed and released by QC and issuance documented by stores before use, and is hereby approved for
commencement of packaging operation.
This is as per the In-Process control reports of: --------------------------- and Date: --------------------------

Q.C: Executive _____________________________ Date: __________________

Q.C. Manager: _____________________________ Date: ___________________

Production Record Checked by: Approval for packing by:

(Production Manager) (Quality Assurance Manager)

Sign/Date Sign/Date
 HMA MEDICAL LIMITED Page 14 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

9.3 PACKAGING

Time Started: Time Finished:

Step Activity Done by: (Production) Checked by (Q.C)

1. Clean the packing line table with a wet clean cloth moist
with 70% IPA solution

2. Visual inspection: Observe for any suspended matter

3. Syringe and needle blistered set cleaning: Ensure all syringe

and needle blistered set are cleaned

4. Finally pack in an inner Box in a row of …. blistered pieces

of……. sets (i.e…….blistered of…….sets). …… inner
boxes are arranged in……decks by…. rows,
totaling………. syringe and needle blistered sets per outer
carton. Seal with Starch paste bond/adhesive tape

5. Stack the outer cartons in the pre-sterilization goods’ store

quarantine on the pallets off the walls while awaiting
sterilization.

6. Reconcile the packing materials & Yield

9.3.1 BATCH RECONCILIATION SHEET FOR COMPONENT PACKING

BATCH RECONCILIATION
QUANTITY BLISTERED SET INNER CARTON SHIPPER CARTON
A. Qty. received

Qty. packed
Qty. sampled
Qty. rejected
Qty. returned
Qty. retained with BMR

Qty. retained by QC Retention Sample

B. Total Qty. used

(B/A) X 100 = % Yield
Remarks: Give justification for any higher % rejection

If rejection is high due to manufacturers defect, then inform manufacturer through the General Manager. Destroy the
material after being checked by QA with the authorization of the General Manager after the approval by the QA
manager in the presence of QA Executive.

Checked by: Destruction Recommended Approved by Quality Assurance Authorized by:

QC Officer: by QCM Manager GM:
 HMA MEDICAL LIMITED Page 15 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

Sr. No. 1 2 3 4 5 Total Qty.

Date:

Qty. transferred:
Shippers + Loss

Transferred by

Received by

9.3.2 TRANSFER TO STERILIZATION CHAMBER

10.0STERILIZATION PROCEDURE
10.1Line Clearance – Sterilization Chamber: SOP No.: HMA/PRD/SOP004-03, HMA/PRD/SOP015-00
Previous Product: UNIQUE ID. NO:

Check List Checked by (Production) Verified by (QC)

Area Cleanliness (floor, walls, ceiling).

Check the cleanliness of the Autoclave

Ensure absence of materials from Previous product/batch

Chemical / Biological Indicators paper is in place

10.2TERMINAL STERILISATION BY ETHYLENE OXIDE GAS AS PER SOP No.: HMA/PRD/SOP016-03

Time
Steps Particulars Done By Checked By
From To
1 Outer cartons containing blistered syringe and needle sets in
inner cartons were arranged in the sterilization Chamber so as to
occupy not more than 80% of the entire volume of the chamber
2 Biological-chemical indicators were inserted at strategic
locations where access of gas is most remote according to the
earlier mapping of the chamber’s inner space
3 The door of the sterilizing chamber was closed pneumatically
after loading the products
4 Sterilization parameters for the batch were set at following
conditions-
* Sterilization Temp.: 56oC
* Chamber Pressure: -48kPa to -50kPa
* Sterilization time: 5 hours.
5 Sterilization period
6 Cycle period
7 After completion of sterilization cycle, off -loading was done
and the sterilized syringe and needle blistered sets in shipper
cartons were arranged on packing pallets.

8 Chemical-biological indicator was checked by Operator in charge & Q.C. Officer and attached to DHR

Sterilization:
Done By Checked By Verified By
Operator: Production Supervisor: Q.C. Executive:
 HMA MEDICAL LIMITED Page 16 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

Product description: Unique ID. No Machine no: Date

Retention sample: Total pack quantity:

11.0 FINAL BATCH RECONCILLATION

Components Material Unique ID. Received Rejected Returned Quantity
code No Quantity Quantity and return no

Barrel
Plunger
Hub
Cap
Printed barrel
Assembled syringe
Assembled needle
Cannula
Blistered set
PVC Film
Dialyzing Paper
Inner Carton
Sealing Tape
Shipper Carton
E O gas

12.0 POST STERILIZATION INSPECTION AND TESTING

Sterilized products were relocated from the sterilization unit and to the quarantine until the batch has been tested for
sterility by the QC laboratory (Microbiology) for 14 days incubation period. The batch was checked to verify the
product and quantities sent to the sterilizer have been relocated and reconciled. The chemical change indicator tape
was verified.

12.1 Intimate Quality Control of completion & Sampling.

Intimation Given by______________ Time: ______________Date: ________________

12.2 Sampling Details:

Sampled Quantity: _____________________

Sampling Done by: _____________________

Time: _________ Date: __________________

13.0 INSPECTION AND RELEASE PROCEDURES

The Physicochemical, Pyrogen and Sterility Tests were performed. Sterility test was done and monitored for 14days
incubation period while the products were in quarantine. The product was released when it has passed the
Physicochemical, Pyrogen and Sterility Tests. Release of product shall be as per SOP No.: HMA/QAD/SOP007-03

14.0 DEVIATION APPROVAL SHEET

 HMA MEDICAL LIMITED Page 17 of 18
Plot 9, Block 4, Transit Camp Road, Ilorin, Kwara State, Nigeria.
DEVICE HISTORY RECORD

DEVIATION REASON AND JUSTIFICATION PROPOSED BY. REVIEWED BY: APPROVED BY:
(QCM) (QAM)

AUTHORIZED
BY: (GM)

15.0 BATCH REVIEW

Release certificate No: Date:

Product
Unique ID No.
Manufacturing Date
Expiry Date
In process Analytical Report No. & AR status
Finished product Analytical report No & AR status
Qty. Packed and released for Sale
(Shippers carton + Loss)

Batch Document Enclosures:

Chemical-Biological Indicator
Certificate of analysis
Empty batch coded pouch of blistered set Start
Confirmation of retention Sample Units of …………………….

This is to certify that the batch has been manufactured and packed as per the laid down standard procedures & all documents
have been Verified.

Production Manager Q.C Manager

Sign/Date: Sign/Date:

BATCH RELEASE APPROVED BY:

The documents are verified and the batch found to comply with ISO 7866, & ISO 7864, specifications, in-house
specification and duly released for Sale and distribution.

Quality Assurance Manager: ________________________ Sign/Date: __________________