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GMP MEDICARE SDN.

BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 1 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 49 49 49 48 48 49 47 48 48 48 49 49 50 50 51 50 49 50 50 50 49 49 49 48

Alkaline Tank 1 50 - 70 62 62 60 60 60 61 61 60 61 62 62 59 62 62 62 62 63 62 63 63 59 61 62 62

Alkaline Tank 2 50 - 70 69 68 67 68 67 66 66 68 68 69 65 67 68 71 71 71 70 70 67 69 70 68 69 66

Coagulant Tank 50 - 60 56 55 55 55 55 56 55 55 55 55 54 56 56 55 57 57 57 56 56 56 57 56 57 55

Coagulant Oven 1 100 - 200 144 145 147 148 149 144 145 147 147 147 147 144 144 136 130 133 132 130 128 130 130 130 132 139

Coagulant Oven 2 100 - 200 140 139 143 142 145 140 141 138 143 141 136 140 140 130 129 129 129 127 127 124 126 126 124 135
Former Temp
Before Latex 65 - 75 64 66 65 65 66 66 66 66 65 66 65 66 69 70 69 69 67 67 65 64 64 65 64 64
Tank 1
Latex Tank 1 45 - 55 42 41 41 42 41 41 42 42 42 41 39 42 42 44 43 44 43 43 43 41 41 41 39 41

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 42 42 41 43 44 44 43 43 43 42 43 45 45 45 45 45 44 44 43 43 44 43 44 43
Tank 2
Latex Tank 2 32 - 36 32 33 33 33 33 32 33 32 33 32 32 32 33 33 35 35 34 35 49 34 32 32 32 32

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 46 47 47 47 48 45 47 45 47 47 48 49 49 50 50 50 51 51 51 48 49 50 49 46

Pre-Leaching T2 55 - 65 66 48 62 56 47 64 68 66 67 65 66 67 66 56 56 54 55 54 54 52 53 46 42 46

Pre-Leaching T3 45 - 55 50 50 50 49 48 49 49 50 49 50 49 51 53 51 49 46 47 48 48 47 47 47 50 51

Pre-Leaching T4 45 - 55 38 36 37 37 36 38 38 38 36 36 38 39 40 41 41 38 37 38 38 38 36 35 36 37
Date Monday, October 08, 2018
Line Line 1

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 114 114 114 113 111 114 115 113 114 114 110 114 114 115 114 114 114 114 114 113 115 114 111 115
(L1 – L10)
Main Oven Z3
100 - 130 116 116 114 114 114 114 116 114 116 116 116 116 116 116 116 116 116 112 116 116 112 116 112 116
(L1 - L10)
Main Oven Z4
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z5
100 - 130 120 120 120 120 118 120 118 118 120 116 120 117 121 117 121 121 120 121 121 120 120 120 120 120
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 120 119 120 119 120 119 119 119 115 119 119 120 120 120 120 120 120 120 119 120 120 116 120
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Cooling Tank 3 50 - 70 59 57 58 57 56 57 58 58 57 57 57 58 59 63 65 59 57 58 59 59 56 56 60 57

Cooling Tank 4 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 1 40 - 60 45 44 41 40 41 42 42 42 43 44 44 46 47 48 49 47 46 45 45 41 41 40 42 41

Chlorine Tank 2 40 - 60 40 38 39 39 39 38 38 38 38 37 39 39 40 41 42 42 40 41 40 40 39 39 39 39

Soak Rinsing
40 - 70 38 38 36 37 36 37 36 37 36 36 36 37 37 39 40 40 39 39 36 37 37 36 36 36
Tank
Post Rinsing
60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank 1
Post Rinsing
60 - 80 38 38 39 36 38 38 38 37 37 37 36 38 37 39 40 41 41 40 40 39 38 39 39 38
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 42 43 43 43 43 43 43 43 44 44 44 44 43 41 43 43 43 41 43 43 43 43 43 43

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 2 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 49 48 49 49 49 49 46 48 48 52 52 54 55 54 53 55 54 54 54 54 54 54 54 54

Alkaline Tank 1 50 - 70 61 59 59 60 60 60 60 58 60 61 61 62 63 63 63 62 62 63 63 63 63 61 61 62

Alkaline Tank 2 50 - 70 57 57 57 55 57 54 57 55 55 58 58 60 61 61 60 61 61 61 61 60 59 59 59 60

Coagulant Tank 50 - 60 56 56 54 55 54 56 56 54 56 56 56 57 54 58 58 57 56 57 55 56 56 55 54 51

Coagulant Oven 1 100 - 200 115 113 119 121 119 121 121 121 121 121 117 118 118 118 117 117 117 115 117 117 117 115 119 115

Coagulant Oven 2 100 - 200 114 116 114 114 114 114 116 116 116 116 117 114 114 114 115 115 115 113 115 115 111 113 116 116
Former Temp
Before Latex 65 - 75 57 58 58 59 56 56 59 58 58 57 60 61 61 62 64 61 62 61 61 59 59 59 57 56
Tank 1
Latex Tank 1 45 - 55 42 42 41 41 41 42 42 42 43 42 42 42 44 43 44 44 44 43 43 43 41 41 42 41

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 41 41 41 40 41 41 41 40 41 41 42 43 43 42 44 43 42 41 43 40 41 41 41 40
Tank 2
Latex Tank 2 32 - 36 35 36 35 35 34 36 36 35 36 35 35 36 37 36 36 37 38 37 37 37 36 36 35 36

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 47 47 46 46 47 47 48 48 47 47 49 50 51 51 53 51 51 49 51 50 49 49 49 48

Pre-Leaching T2 55 - 65 57 57 55 55 56 56 56 56 55 56 40 56 62 56 52 54 56 60 60 59 60 60 61 61

Pre-Leaching T3 45 - 55 51 50 51 52 52 52 51 53 53 54 52 50 52 51 51 50 52 55 57 57 57 55 54 51

Pre-Leaching T4 45 - 55 40 41 41 41 42 41 41 41 41 42 43 43 45 45 45 43 42 42 43 42 41 40 41 41
Date Monday, October 08, 2018
Line Line 2

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 121 121 119 121 119 121 119 119 121 121 121 121 121 121 117 121 121 121 117 121 121 121 120 121
(L1 – L10)
Main Oven Z3
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z4
100 - 130 119 121 121 121 121 121 121 119 121 121 121 120 121 121 117 121 121 121 121 121 121 121 117 121
(L1 - L10)
Main Oven Z5
100 - 130 118 120 120 118 120 118 116 118 120 120 120 120 116 120 120 120 120 120 120 116 120 120 120 120
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 115 119 117 116 117 119 119 114 114 115 117 117 119 120 120 120 120 120 120 119 120 120 120 115
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 73 73 73 74 72 72 73 75 77 72 73 72 73 73 71 73 74 72 74 74 72 70 73 71

Cooling Tank 3 50 - 70 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Cooling Tank 4 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 1 40 - 60 49 49 48 46 48 48 47 48 47 48 50 51 51 51 53 53 52 51 49 47 47 49 46 46

Chlorine Tank 2 40 - 60 39 40 40 40 40 39 40 39 40 39 40 42 41 40 40 39 41 40 41 41 40 38 41 40

Soak Rinsing
40 - 70 42 41 40 40 40 41 39 40 40 39 41 42 41 43 43 39 42 43 41 40 40 40 40 41
Tank
Post Rinsing
60 - 80 42 43 42 41 40 42 41 41 40 40 40 42 44 46 46 48 46 44 42 45 43 42 42 43
Tank 1
Post Rinsing
60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank 2
Final Drying
100 - 130 130 130 130 133 132 130 130 132 127 133 128 133 132 132 133 133 133 128 132 132 132 133 131 132
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 43 43 42 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 3 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 61 59 60 59 61 62 61 60 62 61 62 63 63 63 63 61 61 61 63 61 61 62 62 61

Alkaline Tank 1 50 - 70 66 61 57 58 61 62 63 63 63 64 63 63 66 65 66 65 64 61 63 65 64 65 63 63

Alkaline Tank 2 50 - 70 70 65 59 58 59 66 63 65 62 64 62 64 65 65 64 66 63 65 64 65 65 65 62 64

Coagulant Tank 50 - 60 57 55 57 57 56 56 54 52 56 54 55 57 58 57 57 57 59 58 54 55 53 55 57 55

Coagulant Oven 1 100 - 200 113 114 112 114 112 112 112 112 112 114 114 114 114 114 112 113 111 110 112 113 113 113 113 112

Coagulant Oven 2 100 - 200 113 115 115 115 113 115 115 115 115 113 115 115 115 115 110 115 112 114 111 113 116 113 113 113
Former Temp
Before Latex 65 - 75 66 66 66 67 67 65 67 66 68 73 68 70 72 71 71 72 69 69 63 68 64 67 66 65
Tank 1
Latex Tank 1 45 - 55 40 39 39 39 39 39 40 39 39 39 39 39 40 40 41 40 41 40 41 40 39 40 39 40

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 40 41 41 41 41 41 41 40 40 40 41 42 41 42 42 43 41 40 43 40 39 40 40 39
Tank 2
Latex Tank 2 32 - 36 33 32 32 33 32 33 32 32 33 31 33 32 32 33 32 33 32 32 32 33 32 32 33 33

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Pre-Leaching T2 55 - 65 46 49 48 48 50 51 50 49 54 59 56 50 53 54 56 55 54 54 55 59 63 65 66 65

Pre-Leaching T3 45 - 55 63 61 64 64 64 62 62 60 62 41 50 64 63 63 62 63 63 65 63 66 63 64 67 66

Pre-Leaching T4 45 - 55 55 55 57 58 57 56 58 54 58 55 50 51 54 55 54 54 55 53 56 57 55 54 54 55
Date Monday, October 08, 2018
Line Line 3

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 130 130 130 128 130 128 130 128 130 130 130 129 128 130 121 126 130 130 130 130 122 129 125 121
(L1 – L10)
Main Oven Z3
100 - 130 130 128 130 130 130 130 130 128 130 130 130 126 130 130 130 130 126 130 130 126 130 125 125 130
(L1 - L10)
Main Oven Z4
100 - 130 129 129 130 129 127 129 129 130 126 130 121 130 129 130 130 129 129 129 130 130 129 130 125 130
(L1 - L10)
Main Oven Z5
100 - 130 129 129 130 132 131 132 132 131 131 131 131 123 131 132 128 132 131 132 132 128 127 131 131 131
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 41 42 41 40 41 41 41 42 39 40 39 43 43 45 47 47 45 41 44 45 44 41 38 42

Cooling Tank 3 50 - 70 38 38 37 37 37 37 38 37 38 35 36 38 38 38 37 38 38 38 37 37 37 37 37 37

Cooling Tank 4 40 - 60 36 36 36 35 37 36 36 36 35 38 37 36 37 37 37 36 37 37 37 36 36 37 37 37

Chlorine Tank 1 40 - 60 45 46 45 42 46 47 44 45 44 42 43 46 49 49 50 48 46 47 46 43 43 47 47 45

Chlorine Tank 2 40 - 60 34 33 33 34 32 34 34 33 34 34 34 34 33 34 34 34 34 34 34 34 33 33 33 33

Soak Rinsing
40 - 70 67 65 67 69 71 71 70 69 77 67 66 60 65 64 66 67 65 67 64 65 65 67 68 68
Tank
Post Rinsing
60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank 1
Post Rinsing
60 - 80 56 57 57 53 56 58 57 59 63 60 55 55 53 55 55 56 57 58 57 56 54 56 54 54
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 130 130 131 131 130 128 130 128 130 131 131 131 132 128 132 132 130 130 130 132 131 130 130 125
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 43 43 41 43 43 43 43 43 43 43 43 42 42 42 42 42 42 42 42 41 43 43 43 43

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 4 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 52 52 53 59 40 59 66 63 57 58 54 58 61 62 64 64 63 61 62 63 62 59 59 57

Alkaline Tank 1 50 - 70 60 60 59 60 42 42 60 59 57 56 56 59 61 58 63 63 63 63 63 63 62 61 60 57

Alkaline Tank 2 50 - 70 61 61 60 61 60 55 56 58 58 57 59 60 62 65 66 64 66 65 66 66 64 64 56 34

Coagulant Tank 50 - 60 56 56 56 56 57 55 54 55 53 55 54 53 57 57 58 56 59 59 59 59 59 57 57 57

Coagulant Oven 1 100 - 200 123 123 124 125 125 127 131 129 131 128 132 127 130 132 132 128 132 132 133 132 129 131 133 136

Coagulant Oven 2 100 - 200 119 121 120 123 117 124 125 123 123 126 129 127 128 128 130 128 130 130 130 130 130 130 125 123
Former Temp
Before Latex 65 - 75 71 72 71 73 67 68 72 72 69 73 74 74 76 78 77 76 78 77 76 75 75 74 72 74
Tank 1
Latex Tank 1 45 - 55 40 40 40 40 25 OFF 38 39 41 41 42 42 43 44 43 43 43 43 42 42 42 41 42 43

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 45 45 45 46 51 49 46 45 44 44 47 47 48 46 48 48 47 47 47 46 46 45 45 45
Tank 2
Latex Tank 2 32 - 36 32 30 32 31 32 32 32 30 32 32 32 32 32 32 32 32 32 33 32 32 32 32 32 32

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 50 49 50 49 52 51 50 49 48 49 47 49 46 45 48 48 51 49 52 50 51 49 42 46

Pre-Leaching T2 55 - 65 55 51 53 52 53 54 54 54 58 57 51 54 57 60 66 66 58 61 58 59 57 58 54 55

Pre-Leaching T3 45 - 55 43 47 50 47 56 60 53 52 52 53 54 58 58 53 51 50 49 50 49 50 49 49 48 48

Pre-Leaching T4 45 - 55 49 55 54 50 38 46 47 45 46 47 46 49 50 50 50 49 49 47 47 47 46 46 47 46
Date Monday, October 08, 2018
Line Line 4

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 118 116 118 118 117 121 120 120 120 120 116 116 121 120 121 121 120 121 120 121 121 121 121 121
(L1 – L10)
Main Oven Z3
100 - 130 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 121 120 121 121 121
(L1 - L10)
Main Oven Z4
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z5
100 - 130 118 120 120 118 120 120 118 120 116 120 120 120 120 120 120 120 120 120 120 120 116 116 116 120
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 119 119 117 119 117 119 115 119 119 119 119 119 115 119 119 119 119 119 119 115 119 115 119 119
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 41 40 40 40 40 40 40 39 40 40 39 41 41 40 43 41 41 41 41 42 40 38 41 40

Cooling Tank 3 50 - 70 68 68 70 70 70 70 70 69 68 70 70 68 71 72 72 72 72 71 68 68 70 70 70 70

Cooling Tank 4 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 1 40 - 60 49 49 49 49 49 50 50 48 48 48 49 49 53 52 54 53 51 48 52 50 50 47 49 49

Chlorine Tank 2 40 - 60 48 50 50 48 49 49 49 50 50 50 48 50 50 50 49 50 50 50 50 50 46 48 49 49

Soak Rinsing
40 - 70 48 48 48 47 47 48 47 46 45 47 47 48 46 48 48 48 48 46 48 48 47 46 47 47
Tank
Post Rinsing
60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank 1
Post Rinsing
60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank 2
Final Drying
100 - 130 108 111 112 111 111 108 110 111 105 105 108 139 132 116 116 116 117 116 112 113 117 112 117 116
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 44 45 45 45 45 45 45 44 45 45 45 45 44 43 43 43 43 43 45 45 45 45 45 45

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 5 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 72 76 78 74 78 76 74 76 73 74 72 75 75 74 72 72 72 74 76 73 71 75 72 73

Alkaline Tank 1 50 - 70 57 57 60 60 58 58 59 59 55 58 57 55 57 57 55 55 53 54 56 55 57 58 57 55

Alkaline Tank 2 50 - 70 57 57 60 60 58 58 59 59 55 58 57 55 57 57 55 55 53 54 56 55 57 58 57 55

Coagulant Tank 50 - 60 53 51 54 54 53 51 50 51 52 53 55 52 51 50 52 51 53 53 54 50 54 53 53 52

Coagulant Oven 1 100 - 200 149 147 149 147 149 144 147 144 147 149 147 149 149 149 149 144 147 149 147 149 149 147 149 147

Coagulant Oven 2 100 - 200 144 144 144 144 141 144 144 141 144 144 144 141 144 142 144 144 144 144 144 144 142 139 141 144
Former Temp
Before Latex 65 - 75 373 366 366 366 366 347 360 360 379 360 366 360 360 373 354 353 354 366 360 366 373 341 354 354
Tank 1
Latex Tank 1 45 - 55 39 37 39 36 39 39 37 39 40 37 37 41 38 37 41 41 39 41 39 39 39 39 38 40

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 51 50 48 51 49 48 51 48 48 51 50 52 51 50 50 51 50 48 51 51 49 47 48 49
Tank 2
Latex Tank 2 32 - 36 31 31 31 32 32 31 31 30 32 31 31 31 33 33 33 33 32 31 32 32 33 32 32 31

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 48 48 47 47 47 46 46 46 47 46 45 45 48 47 47 47 45 43 47 47 44 46 45 45

Pre-Leaching T2 55 - 65 60 63 61 61 63 62 63 62 59 57 52 48 49 51 49 51 49 50 50 49 50 53 52 52

Pre-Leaching T3 45 - 55 56 55 52 54 54 56 55 55 54 51 53 53 48 51 51 52 50 53 53 52 53 49 49 52

Pre-Leaching T4 45 - 55 48 48 49 48 46 48 50 49 48 48 49 48 50 50 52 52 50 52 47 49 50 48 48 48
Date Monday, October 08, 2018
Line Line 5

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 126 122 123 125 126 126 125 123 125 125 125 122 126 127 123 128 127 126 122 126 122 122 125 121
(L1 – L10)
Main Oven Z3
100 - 130 128 130 130 128 130 128 130 130 130 131 130 130 130 130 131 131 130 126 130 131 122 122 130 130
(L1 - L10)
Main Oven Z4
100 - 130 130 128 130 130 130 130 126 130 130 130 130 130 126 130 130 130 130 130 130 130 130 130 130 130
(L1 - L10)
Main Oven Z5
100 - 130 129 131 131 131 129 131 129 129 127 131 131 131 131 131 131 131 131 131 131 131 131 131 131 131
(L1 - L10)
Main Oven Z6
(L1 – L10 except N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
L5 & L6)
Main Oven Z7
(L1 – L10 except N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 70 68 68 70 68 70 71 69 72 72 67 67 72 68 73 73 73 73 70 70 70 62 73 72

Cooling Tank 3 50 - 70 68 64 68 68 66 68 65 65 63 67 63 68 63 68 68 66 66 66 63 66 66 66 68 61

Cooling Tank 4 40 - 60 56 60 59 58 60 59 57 61 61 61 60 62 60 58 58 56 59 58 56 60 60 62 60 60

Chlorine Tank 1 40 - 60 40 40 41 39 40 39 38 40 47 44 42 39 37 35 36 33 35 36 36 35 36 33 33 35

Chlorine Tank 2 40 - 60 34 35 35 36 33 34 35 35 33 37 37 35 34 36 37 37 36 34 33 36 32 35 36 33

Soak Rinsing
40 - 70 54 54 56 55 55 54 53 52 55 53 54 48 56 58 57 59 57 58 57 54 55 56 50 56
Tank
Post Rinsing
60 - 80 41 41 41 40 39 38 38 38 39 38 39 40 39 41 44 43 41 43 42 42 40 41 40 37
Tank 1
Post Rinsing
60 - 80 65 68 68 66 70 69 71 70 68 73 71 71 70 67 70 70 72 67 70 65 69 71 69 66
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 124 130 130 126 130 130 130 126 130 130 130 130 126 126 130 130 130 130 130 130 130 130 130 130
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 54 54 54 54 54 54 54 54 54 53 53 54 54 53 52 54 54 53 54 54 54 54 54 54

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 6 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 62 61 61 57 57 58 60 59 59 58 57 56 56 55 55 54 54 54 54 53 52 54 54 53

Alkaline Tank 1 50 - 70 49 49 49 51 48 51 51 51 48 48 48 49 48 48 48 49 46 47 47 47 46 44 46 47

Alkaline Tank 2 50 - 70 53 52 52 56 56 55 54 55 53 57 62 59 61 60 59 60 58 58 60 58 59 59 56 60

Coagulant Tank 50 - 60 55 51 55 54 54 52 55 54 53 53 692 856 584 826 826 870 841 856 841 841 841 870 811 812

Coagulant Oven 1 100 - 200 143 143 146 146 145 145 145 141 146 146 146 146 146 144 146 145 142 145 145 146 145 144 142 142

Coagulant Oven 2 100 - 200 140 143 140 143 143 143 142 143 143 140 140 140 140 138 137 140 138 139 139 142 142 142 142 139
Former Temp
Before Latex 65 - 75 65 63 65 66 66 66 64 66 63 64 66 67 67 68 68 63 64 65 65 62 62 63 65 62
Tank 1
Latex Tank 1 45 - 55 42 42 42 39 39 40 42 41 44 43 43 41 41 43 44 42 41 40 42 40 41 40 40 43

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 44 42 44 44 45 44 44 43 43 43 44 45 44 44 44 43 40 42 42 42 42 43 41 43
Tank 2
Latex Tank 2 32 - 36 33 34 32 35 33 34 32 32 30 30 30 30 29 31 30 30 31 31 31 33 32 31 29 31

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 49 50 50 48 46 48 48 48 51 49 46 51 50 50 48 47 43 43 45 45 43 42 40 46

Pre-Leaching T2 55 - 65 48 48 50 49 47 44 47 49 49 47 41 43 53 52 50 52 52 50 53 51 52 51 52 52

Pre-Leaching T3 45 - 55 54 53 50 52 51 53 48 50 48 51 50 52 54 55 56 51 55 55 55 53 53 54 53 53

Pre-Leaching T4 45 - 55 41 39 40 43 41 40 41 41 40 42 44 42 45 47 46 43 44 42 42 41 42 40 41 40
Date Monday, October 08, 2018
Line Line 6

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 99 99 99 99 101 99 99 101 101 98 101 101 101 98 98 101 101 101 101 98 101 101 101 101
(L1 – L10)
Main Oven Z3
100 - 130 100 100 100 100 97 97 100 99 100 100 100 101 101 101 101 101 100 100 100 97 100 100 100 100
(L1 - L10)
Main Oven Z4
100 - 130 101 101 101 101 101 99 99 99 97 101 94 101 101 98 101 101 101 101 98 98 101 101 101 98
(L1 - L10)
Main Oven Z5
100 - 130 101 100 102 101 100 101 101 101 102 101 101 98 102 101 101 101 101 101 98 101 101 98 101 101
(L1 - L10)
Main Oven Z6
(L1 – L10 except N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
L5 & L6)
Main Oven Z7
(L1 – L10 except N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
L5 & L6)
Main Oven Z8
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
(only L7 – L10)

Cooling Tank 2 60 - 80 66 64 62 63 64 64 65 60 64 64 64 64 59 63 63 68 63 66 62 66 64 59 66 64

Cooling Tank 3 50 - 70 59 61 57 59 59 61 58 57 62 60 56 60 60 59 63 61 58 62 57 61 59 62 60 60

Cooling Tank 4 40 - 60 60 55 55 55 58 58 57 56 58 58 59 60 57 55 52 60 60 55 59 59 55 56 57 59

Chlorine Tank 1 40 - 60 45 44 45 46 44 45 44 47 45 45 46 46 50 50 51 48 46 46 45 43 46 44 48 48

Chlorine Tank 2 40 - 60 36 34 37 36 36 36 37 36 35 35 35 35 33 38 38 35 35 38 37 37 35 32 36 37

Soak Rinsing
40 - 70 40 40 40 40 39 40 40 38 39 40 40 40 41 40 40 41 39 38 37 41 40 41 40 41
Tank
Post Rinsing
60 - 80 40 41 38 40 39 39 39 38 36 40 37 39 38 38 41 41 41 40 41 36 41 37 38 36
Tank 1
Post Rinsing
60 - 80 57 58 58 58 60 58 56 57 59 57 59 59 56 60 58 59 61 57 58 60 58 59 59 59
Tank 2
Final Drying
100 - 130 145 145 148 148 145 147 147 145 152 153 153 154 154 149 142 142 142 142 142 142 142 142 142 142
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52 52

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 7 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 1320 1297 1298 1298 1298 1298 1276 1320 1274 1038 65 43 43 42 44 44 43 42 42 42 40 1081 1320 1276

Alkaline Tank 1 50 - 70 56 55 55 57 58 57 58 56 55 58 58 59 59 58 61 59 59 59 60 59 57 58 59 57

Alkaline Tank 2 50 - 70 56 58 61 62 63 62 64 64 63 65 65 64 65 65 67 66 67 64 66 66 65 64 63 63

Coagulant Tank 50 - 60 54 52 53 52 52 51 53 52 52 53 53 53 52 55 55 53 54 53 52 51 53 52 52 51

Coagulant Oven 1 100 - 200 116 120 119 118 120 118 120 120 120 120 122 120 118 119 112 118 116 116 118 118 116 118 118 118

Coagulant Oven 2 100 - 200 119 120 120 120 120 121 120 121 120 122 124 121 121 118 117 119 117 119 119 119 117 119 119 119
Former Temp
Before Latex 65 - 75 52 59 61 60 62 61 60 60 62 62 63 63 63 63 63 60 60 61 60 61 60 63 57 60
Tank 1
Latex Tank 1 45 - 55 36 24 39 39 39 40 39 40 40 41 41 42 43 43 41 43 41 42 42 41 40 41 41 40

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 42 39 40 41 39 40 39 40 41 41 41 41 41 42 41 39 38 38 40 40 38 38 39 39
Tank 2
Latex Tank 2 32 - 36 31 29 30 31 32 31 31 32 33 32 32 31 34 33 33 33 33 32 32 32 31 33 32 32

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 62 67 59 59 58 57 57 57 57 56 61 53 48 55 63 60 57 60 58 58 57 59 57 58

Pre-Leaching T2 55 - 65 71 69 65 65 66 64 69 64 69 67 70 67 68 69 66 66 67 66 69 69 68 67 69 67

Pre-Leaching T3 45 - 55 39 42 43 44 43 43 41 42 43 44 43 44 44 43 43 43 44 190 431 432 446 436 443 460

Pre-Leaching T4 45 - 55 58 60 54 52 55 55 53 52 53 54 56 57 57 55 53 53 51 51 52 55 56 58 55 54
Date Monday, October 08, 2018
Line Line 7

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 130 130 130 130 130 126 128 128 126 130 130 130 130 125 130 130 130 130 126 130 129 130 130 130
(L1 – L10)
Main Oven Z3
100 - 130 128 128 128 126 128 128 126 128 128 128 129 130 126 129 130 125 128 123 127 128 128 127 123 128
(L1 - L10)
Main Oven Z4
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z5
100 - 130 130 130 130 130 128 128 130 130 130 130 130 130 130 126 130 130 130 130 130 130 130 130 130 130
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 130 128 130 128 127 127 130 127 125 130 130 125 130 130 130 130 130 130 130 125 125 121 125 130
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(only L7 – L10)

Cooling Tank 2 60 - 80 68 69 67 66 67 66 68 68 69 69 67 70 70 68 68 69 68 70 67 67 70 69 64 69

Cooling Tank 3 50 - 70 62 63 61 62 62 64 59 59 63 63 61 63 64 62 58 63 64 62 59 61 64 62 62 64

Cooling Tank 4 40 - 60 58 58 59 59 59 60 59 59 57 57 58 58 58 59 57 61 59 55 58 58 58 58 61 61

Chlorine Tank 1 40 - 60 48 50 49 50 49 50 49 50 51 48 49 48 49 47 50 50 49 50 52 51 49 48 51 46

Chlorine Tank 2 40 - 60 42 43 42 43 44 43 44 44 42 44 43 44 46 45 47 45 45 44 45 43 43 44 43 43

Soak Rinsing
40 - 70 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank
Post Rinsing
60 - 80 44 44 44 44 44 44 43 45 41 43 42 45 44 45 45 46 44 44 45 45 44 44 43 44
Tank 1
Post Rinsing
60 - 80 44 48 43 42 44 44 44 44 44 40 42 45 42 44 46 46 43 44 43 45 45 44 43 45
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49 49

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 8 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 50 - 70 58 58 58 59 57 59 58 58 59 59 60 59 61 61 62 59 61 61 63 64 61 59 55 54

Alkaline Tank 1 50 - 70 65 63 65 65 65 64 65 59 66 64 66 66 67 66 66 69 68 67 68 70 68 66 63 63

Alkaline Tank 2 50 - 70 70 69 70 71 69 69 69 70 70 69 72 72 72 70 73 74 70 74 73 75 74 72 71 68

Coagulant Tank 50 - 60 54 55 55 55 53 55 55 55 55 56 55 57 55 56 55 56 55 57 55 57 55 54 56 55

Coagulant Oven 1 100 - 200 114 117 118 116 118 116 118 112 120 121 118 118 118 117 113 113 113 111 113 111 113 113 117 118

Coagulant Oven 2 100 - 200 113 109 113 113 113 115 113 115 117 117 117 117 117 112 111 111 111 111 111 111 110 109 114 115
Former Temp
Before Latex 65 - 75 60 60 61 60 60 62 62 61 61 59 62 60 64 62 61 60 60 59 59 61 59 57 59 60
Tank 1
Latex Tank 1 45 - 55 40 40 40 40 40 41 40 40 41 41 42 41 41 42 43 42 40 41 40 41 41 41 40 40

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 41 39 40 42 41 41 39 40 41 42 42 42 42 41 42 41 38 39 39 41 39 39 38 41
Tank 2
Latex Tank 2 32 - 36 30 29 30 30 30 30 30 29 29 30 30 29 30 30 30 29 30 28 30 30 30 30 30 30

Latex Oven 2
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp

Pre-Leaching T1 55 - 65 47 44 46 46 43 45 45 43 45 50 44 52 48 49 48 54 49 51 46 46 49 47 49 52

Pre-Leaching T2 55 - 65 68 69 69 69 67 67 68 68 68 66 67 67 68 67 67 69 68 68 69 69 69 68 67 67

Pre-Leaching T3 45 - 55 48 49 48 49 49 49 48 48 49 50 50 50 50 51 51 48 45 44 47 49 48 44 46 49

Pre-Leaching T4 45 - 55 54 54 54 52 50 54 53 54 52 54 54 55 56 60 60 61 59 59 60 58 60 57 59 59
Date Monday, October 08, 2018
Line Line 8

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 134 134 134 132 134 134 134 132 134 134 134 134 134 135 135 134 134 135 134 134 134 134 134 134
(L1 – L10)
Main Oven Z3
100 - 130 128 131 130 131 129 129 131 132 132 128 132 133 128 133 129 132 126 130 131 134 133 131 131 132
(L1 - L10)
Main Oven Z4
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z5
100 - 130 134 134 134 130 134 134 134 134 130 134 134 134 134 134 134 130 134 134 134 134 134 134 134 134
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 131 131 132 132 131 128 131 131 131 131 132 132 132 132 128 132 131 127 131 133 127 130 131 131
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(only L7 – L10)

Cooling Tank 2 60 - 80 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Cooling Tank 3 50 - 70 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Cooling Tank 4 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 1 40 - 60 46 45 46 45 46 46 47 47 47 47 48 50 50 49 51 47 44 44 43 46 44 44 45 47

Chlorine Tank 2 40 - 60 45 48 47 47 48 47 48 48 48 43 48 45 49 48 48 46 47 48 48 47 47 47 48 48

Soak Rinsing
40 - 70 50 54 53 54 53 54 54 52 54 52 54 55 56 56 56 56 55 55 54 53 53 53 53 53
Tank
Post Rinsing
60 - 80 44 44 45 45 45 44 44 44 42 44 44 44 46 46 44 46 44 46 42 45 45 45 45 44
Tank 1
Post Rinsing
60 - 80 43 42 43 42 42 44 44 44 43 44 44 43 44 44 43 44 43 44 44 44 43 43 43 44
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 66 71 OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 9 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 45 - 70 59 58 58 59 57 59 58 58 58 59 60 59 61 61 59 55 50 45 41 38 37 45 55 57

Alkaline Tank 1 45 - 75 62 63 63 63 61 63 63 63 63 62 62 63 63 64 65 59 51 49 45 41 40 48 59 63

Alkaline Tank 2 45 - 75 67 67 67 66 64 64 66 67 67 66 67 67 68 66 68 58 56 50 48 44 43 48 60 64

Coagulant Tank 45 - 60 54 53 54 55 55 55 52 54 54 55 54 55 55 55 55 53 53 52 51 50 50 51 49 52

Coagulant Oven 1 100 - 200 132 129 132 132 132 129 129 132 132 132 129 128 124 124 OFF OFF OFF OFF OFF OFF OFF 115 131 130

Coagulant Oven 2 100 - 200 127 131 133 131 133 129 133 131 133 133 133 130 126 126 OFF OFF OFF OFF OFF OFF OFF 126 135 137
Former Temp
Before Latex 60 - 75 59 59 59 59 59 58 59 58 58 58 59 61 60 60 54 51 48 46 47 47 44 49 56 59
Tank 1
Latex Tank 1 40 - 55 43 43 44 43 44 42 44 44 44 44 43 45 44 45 OFF OFF OFF OFF OFF OFF OFF OFF 36 43

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 41 41 42 41 41 41 41 41 40 40 42 42 41 42 41 39 37 37 38 38 37 37 39 40
Tank 2
Latex Tank 2 30 - 36 33 33 32 32 32 33 33 33 33 34 33 34 33 32 OFF OFF OFF OFF OFF OFF OFF OFF 23 31

Latex Oven 2
100 - 130 122 119 122 119 119 122 122 121 119 122 122 118 113 113 OFF OFF OFF OFF OFF OFF OFF 90 130 129
Temp

Pre-Leaching T1 50 - 65 44 45 44 43 42 42 42 42 42 42 42 40 39 40 43 38 33 32 34 36 35 38 43 46

Pre-Leaching T2 50 - 65 64 63 64 64 64 64 63 63 64 63 64 64 64 64 57 40 35 34 35 38 38 38 53 62

Pre-Leaching T3 45 - 65 45 46 45 47 45 44 44 46 46 47 47 48 46 44 44 39 36 34 36 40 39 37 42 46

Pre-Leaching T4 40 - 65 49 48 48 49 49 48 49 48 49 49 48 48 50 48 52 50 41 30 31 34 33 32 50 54
Date Monday, October 08, 2018
Line Line 9

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 130 130 130 126 130 126 124 125 130 130 130 131 121 117 OFF OFF OFF OFF OFF OFF OFF 94 121 121
(L1 – L10)
Main Oven Z3
100 - 130 125 125 125 126 125 122 122 123 121 126 126 126 118 119 OFF OFF OFF OFF OFF OFF OFF 91 119 119
(L1 - L10)
Main Oven Z4
100 - 130 121 117 117 121 61 121 121 120 117 121 121 121 121 121 OFF OFF OFF OFF OFF OFF OFF 91 121 121
(L1 - L10)
Main Oven Z5
100 - 130 128 127 127 127 127 122 122 124 126 126 120 118 117 118 OFF OFF OFF OFF OFF OFF OFF 58 119 115
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 130 126 131 131 66 124 124 125 130 131 131 131 121 121 OFF OFF OFF OFF OFF OFF OFF 80 123 121
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(only L7 – L10)

Cooling Tank 2 60 - 80 57 54 54 53 52 53 61 66 68 68 66 68 68 67 67 63 57 43 37 40 38 36 48 60

Cooling Tank 3 50 - 70 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Cooling Tank 4 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 1 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Chlorine Tank 2 40 - 60 39 40 40 39 39 34 35 36 39 39 39 39 39 38 37 34 40 41 41 40 40 37 31 33

Soak Rinsing
40 - 70 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Tank
Post Rinsing
40 - 80 49 48 48 48 47 50 50 50 52 51 54 53 55 55 52 47 45 45 41 41 43 43 49 49
Tank 1
Post Rinsing
40 - 80 42 44 43 40 39 40 39 38 41 41 40 42 40 41 41 50 47 45 43 41 32 34 35 35
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PROCESS PARAMETERS RECORD
NITRILE POWDER-FREE GLOVES

Date Monday, October 08, 2018 Chemical Batch No Chemical Batch No

Line Line 10 Nitric Acid Calcium Nitrate

Machine Operator Alkaline Ammonia

7am – 7pm: PF Coagulant

7pm – 7am:

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10

Acid Tank 45 - 70 59 55 57 58 59 60 56 58 60 59 57 59 56 57 59 53 53 57 56 58 57 54 56 57

Alkaline Tank 1 45 - 75 58 61 60 60 59 61 59 59 58 58 60 56 60 61 57 52 58 55 59 61 59 59 57 60

Alkaline Tank 2 45 - 75 44 44 47 48 46 46 46 46 46 46 45 46 46 46 44 45 46 44 46 48 45 48 47 46

Coagulant Tank 45 - 60 52 53 52 51 52 52 49 52 53 53 51 55 53 53 52 51 54 51 52 54 55 51 49 53

Coagulant Oven 1 100 - 200 141 141 141 141 141 141 142 140 140 142 139 137 135 140 139 139 139 141 142 140 142 142 142 142

Coagulant Oven 2 100 - 200 140 140 140 140 138 140 140 140 140 140 139 137 136 136 136 134 137 138 142 142 142 142 142 142
Former Temp
Before Latex 65 - 75 66 66 69 68 68 66 63 66 69 69 69 66 68 69 69 59 67 67 66 61 64 63 66 68
Tank 1
Latex Tank 1 40 - 55 39 40 40 39 39 39 39 40 40 40 40 41 39 41 40 40 41 40 39 41 41 41 40 41

Latex Oven 1
36 - 40 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Temp
Former Temp
Before Latex 50 - 150 37 39 39 39 38 39 39 37 38 38 41 40 38 41 38 38 35 34 38 35 35 35 38 34
Tank 2
Latex Tank 2 30 - 36 30 31 31 30 30 31 31 32 31 31 32 32 32 30 29 31 31 30 30 30 31 29 29 30

Latex Oven 2
100 - 130 102 102 102 101 102 98 100 99 101 101 100 102 102 102 104 101 102 102 98 102 100 103 101 100
Temp

Pre-Leaching T1 55 - 65 41 39 41 41 41 39 41 41 41 47 42 41 44 47 55 53 56 56 58 57 56 61 58 54

Pre-Leaching T2 55 - 65 52 53 51 52 50 51 49 51 51 51 52 52 52 52 55 53 58 56 55 58 57 59 58 58

Pre-Leaching T3 45 - 65 44 43 44 44 43 43 45 41 43 41 44 42 45 44 45 44 46 46 46 46 47 46 47 47

Pre-Leaching T4 45 - 65 41 43 44 42 40 43 41 43 44 44 44 46 42 44 43 38 36 37 40 41 41 37 37 42
Date Monday, October 08, 2018
Line Line 10

Time

pm am pm

Process Parameter °C 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10
Main Oven Z1
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 – L10)
Main Oven Z2
100 - 130 120 118 118 118 116 120 120 120 116 120 120 120 120 116 120 120 120 116 116 120 120 116 120 120
(L1 – L10)
Main Oven Z3
100 - 130 119 119 115 117 119 119 119 117 119 115 111 119 119 119 115 119 119 115 115 119 119 115 115 115
(L1 - L10)
Main Oven Z4
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(L1 - L10)
Main Oven Z5
100 - 130 123 121 121 124 119 123 121 123 124 120 120 125 121 125 125 124 123 118 123 123 123 114 122 119
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 118 120 120 120 120 116 120 116 120 120 120 120 120 120 116 120 120 120 120 120 120 120 120 116
L5 & L6)
Main Oven Z7
(L1 – L10 except 100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
L5 & L6)
Main Oven Z8
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
(only L7 – L10)

Cooling Tank 2 60 - 80 65 61 62 64 65 60 62 65 63 64 59 64 67 65 67 66 66 60 63 62 60 59 62 58

Cooling Tank 3 50 - 70 55 59 56 60 57 60 56 57 59 61 61 60 60 56 62 62 61 61 54 60 60 59 56 58

Cooling Tank 4 40 - 60 54 53 56 55 56 52 54 55 50 54 56 54 53 48 55 53 53 56 55 55 55 53 53 53

Chlorine Tank 1 40 - 60 45 49 48 48 49 48 49 50 50 43 47 47 46 51 51 47 51 48 48 48 48 45 50 47

Chlorine Tank 2 40 - 60 47 48 48 47 45 47 49 46 43 50 51 47 51 53 52 52 48 49 47 42 47 46 49 44

Soak Rinsing
40 - 70 78 74 76 76 75 77 76 79 79 79 71 80 80 77 75 77 72 74 76 76 70 75 76 76
Tank
Post Rinsing
40 - 80 45 44 43 43 42 43 44 43 41 43 44 44 46 43 42 43 46 43 40 45 44 45 43 45
Tank 1
Post Rinsing
40 - 80 41 42 39 40 40 42 40 40 40 40 43 42 43 41 43 39 43 43 39 42 41 42 39 41
Tank 2
Final Drying
100 - 130 41 77 76 78 76 76 78 79 79 OFF OFF OFF OFF OFF OFF OFF OFF 72 74 76 77 70 76 79
Oven Z1
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Checked by Shift 2: Shift 3:

Remark Shift 2: Shift 3:

Verified by :______________________________

Date :______________________________
Rev.:3 (PR/F01)
GMP MEDICARE SDN. BHD
FACTORY 25
DAILY PRODUCTION OUTPUT
Date: Monday, October 08, 2018

Line Production
1 0
2 0
3 309821
4 316713
5 0
6 0
7 22043
8 0
9 0
10 0

TOTAL ALL: 648577

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