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GMP MEDICARE SDN.

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

Date Thursday, November 15, 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 45 43 44 46 46 46 46 46 44 43 46 44 45 45 35 45 46 45 42 45 46 42 43 45

Alkaline Tank 1 50 - 70 62 59 57 62 63 62 61 OFF 43 59 61 37 61 61 53 63 61 62 62 62 61 58 62 61

Alkaline Tank 2 50 - 70 69 66 66 67 67 65 66 66 51 65 66 68 63 68 67 68 66 67 69 67 67 68 64 67

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

Coagulant Oven 1 100 - 200 157 160 161 161 159 161 163 161 157 161 161 159 155 155 154 152 152 152 152 152 152 152 151 152

Coagulant Oven 2 100 - 200 152 153 156 158 154 156 157 155 155 153 155 154 148 151 150 144 147 146 146 146 142 146 146 147
Former Temp
Before Latex 65 - 75 69 66 65 69 69 69 65 62 64 66 68 65 68 69 65 70 65 69 69 69 67 65 64 60
Tank 1
Latex Tank 1 45 - 55 OFF 33 37 40 40 40 40 40 39 39 40 40 37 38 39 39 35 38 37 39 37 37 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 43 42 38 6 42 27 32 46 45 43 46 46 46 42 48 44 47 47 45 45 47 48 42 42
Tank 2
Latex Tank 2 32 - 36 32 30 32 32 33 33 33 33 33 31 33 31 33 33 32 30 32 31 30 32 32 30 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 45 42 44 42 41 43 44 44 43 43 44 43 44 45 43 43 42 42 43 41 42 45 43 43

Pre-Leaching T2 55 - 65 55 53 51 54 55 57 60 60 58 48 47 45 47 55 54 54 56 55 57 53 53 50 54 50

Pre-Leaching T3 45 - 55 45 44 50 51 52 53 54 54 54 52 48 45 47 47 50 48 50 49 49 51 50 49 48 53

Pre-Leaching T4 45 - 55 38 38 35 38 40 36 34 35 36 31 21 37 38 39 40 42 39 41 40 35 35 38 36 38
Date Thursday, November 15, 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 - 130 128 123 123 123 124 123 119 121 112 120 125 121 123 123 123 123 124 126 126 126 127 126 126 127
(L1 – L10)
Main Oven Z3
100 - 130 131 131 131 131 132 131 131 126 132 131 131 130 131 131 105 131 131 131 127 131 131 131 131 131
(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 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 Z6
(L1 – L10 except 100 - 130 131 131 131 131 130 128 130 129 131 131 131 132 126 131 131 131 127 131 126 131 131 131 131 131
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
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 60 56 61 59 58 60 61 59 61 59 61 61 54 59 61 57 62 60 62 60 53 60 60 57

Cooling Tank 3 50 - 70 55 54 55 56 OFF 35 43 56 56 56 56 54 54 52 56 49 55 46 53 57 57 53 55 57

Cooling Tank 4 40 - 60 49 48 46 49 48 48 45 50 21 47 49 49 49 50 50 47 49 48 48 48 48 48 49 46

Chlorine Tank 1 40 - 60 44 43 43 43 39 42 43 43 41 40 42 43 44 42 43 45 43 43 45 42 43 46 46 46

Chlorine Tank 2 40 - 60 46 45 43 45 46 44 48 48 47 47 47 45 47 45 48 46 48 47 44 44 45 48 45 48

Soak Rinsing
40 - 70 34 34 33 33 33 34 35 34 34 33 25 35 32 34 35 29 34 36 33 35 33 35 34 33
Tank
Post Rinsing
60 - 80 37 36 36 37 37 37 37 38 37 35 37 38 37 38 38 37 36 39 39 37 39 38 38 39
Tank 1
Post Rinsing
60 - 80 38 36 37 37 37 37 38 37 38 33 38 38 38 32 39 39 36 38 38 38 39 39 38 36
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) 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 43 42 44 44 44 44

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 Thursday, November 15, 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 56 52 51 53 53 53 53 53 51 51 53 34 49 55 55 59 58 61 57 59 56 51 56 51

Alkaline Tank 1 50 - 70 62 61 58 61 61 60 59 59 58 59 60 57 59 60 57 59 59 59 58 58 60 59 55 56

Alkaline Tank 2 50 - 70 61 58 59 58 58 59 61 65 66 64 66 65 60 66 65 67 65 64 69 69 66 68 66 61

Coagulant Tank 50 - 60 56 54 54 57 56 56 57 57 57 55 56 55 54 57 57 54 56 57 52 57 51 57 56 45

Coagulant Oven 1 100 - 200 121 119 119 117 120 120 124 124 123 123 123 120 123 122 123 122 116 120 120 118 118 118 118 119

Coagulant Oven 2 100 - 200 117 117 117 116 117 119 112 120 119 119 119 119 117 119 119 117 116 112 116 116 114 110 117 118
Former Temp
Before Latex 65 - 75 58 55 54 55 55 57 58 60 59 57 59 60 61 63 61 59 58 60 60 61 62 60 59 61
Tank 1
Latex Tank 1 45 - 55 40 39 39 5 41 40 41 41 40 39 40 38 37 36 41 41 41 40 41 41 41 40 40 39

Latex Oven 1
36 - 40 126 122 117 117 117 118 118 121 119 118 116 119 117 115 104 106 111 111 108 106 103 100 101 101
Temp
Former Temp
Before Latex 50 - 150 38 37 35 37 38 39 40 40 39 37 41 39 42 41 41 41 42 40 39 41 40 42 40 38
Tank 2
Latex Tank 2 32 - 36 33 32 34 34 35 36 36 36 35 33 36 37 36 37 36 37 35 35 36 36 36 35 35 37

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 44 42 40 42 42 44 46 46 45 43 46 49 48 45 50 44 48 50 51 52 53 52 47 41

Pre-Leaching T2 55 - 65 59 56 52 56 56 56 56 55 54 54 38 53 55 55 55 53 52 55 57 53 51 55 55 56

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

Pre-Leaching T4 45 - 55 40 40 39 41 41 43 43 43 41 41 29 45 46 47 45 48 46 46 44 43 46 44 43 42
Date Thursday, November 15, 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 - 130 131 130 130 130 130 130 131 131 130 130 129 130 130 126 131 130 130 130 130 130 130 130 130 121
(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 - 130 132 131 132 132 130 130 130 133 130 132 131 133 132 131 131 132 132 132 132 132 132 132 131 131
(L1 - L10)
Main Oven Z5
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 Z6
(L1 – L10 except 100 - 130 122 121 121 121 116 126 126 125 122 120 120 120 119 116 116 113 119 120 116 120 118 125 130 130
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
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 67 67 65 65 66 66 62 67 41 66 67 67 65 68 68 69 70 64 68 57 69 64 63 70

Cooling Tank 3 50 - 70 63 57 58 57 59 58 61 62 60 58 61 62 63 52 45 62 63 65 64 64 60 64 62 65

Cooling Tank 4 40 - 60 48 47 45 48 49 47 49 49 46 44 48 47 47 43 49 49 51 49 48 45 51 51 50 52

Chlorine Tank 1 40 - 60 48 48 49 49 OFF 30 48 49 48 45 13 50 50 51 51 49 50 52 50 51 51 52 48 51

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

Soak Rinsing
40 - 70 44 42 43 43 44 45 46 46 45 45 46 46 43 46 46 47 46 45 40 45 44 43 47 44
Tank
Post Rinsing
60 - 80 40 41 40 42 41 41 43 40 40 38 42 41 41 43 43 40 43 38 38 39 36 42 42 39
Tank 1
Post Rinsing
60 - 80 41 41 42 41 40 39 41 42 41 41 42 43 40 43 30 43 42 42 43 42 36 42 42 43
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) 40 40 41 43 43 43 43 43 43 43 43 43 43 43 43 43 36 39 39 39 44 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 Thursday, November 15, 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 51 48 49 50 OFF 31 50 50 48 48 50 48 50 52 52 49 50 51 50 50 48 48 50 50

Alkaline Tank 1 50 - 70 60 58 59 61 61 60 55 31 41 58 49 36 58 61 59 60 57 59 61 61 58 55 54 60

Alkaline Tank 2 50 - 70 65 63 63 64 65 65 65 31 63 61 63 62 61 62 62 62 63 62 59 61 59 59 57 59

Coagulant Tank 50 - 60 56 54 51 56 56 56 56 56 55 56 57 55 56 57 58 54 57 53 55 52 58 53 56 57

Coagulant Oven 1 100 - 200 137 138 139 138 140 140 139 138 136 137 137 135 135 135 135 133 132 125 131 132 132 130 132 132

Coagulant Oven 2 100 - 200 134 135 129 135 135 135 135 134 134 133 135 133 133 133 133 131 130 130 132 131 129 129 127 131
Former Temp
Before Latex 65 - 75 67 66 67 67 66 68 68 68 68 65 68 71 70 73 69 69 68 70 70 66 63 70 67 69
Tank 1
Latex Tank 1 45 - 55 39 39 37 39 39 40 40 40 40 39 40 39 39 40 39 39 40 38 40 41 39 39 39 39

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 OFF 31 39 40 40 39 40 40 39 39 41 42 42 42 38 41 42 42 42 42 40 41 42 39
Tank 2
Latex Tank 2 32 - 36 33 33 32 33 33 33 33 33 32 33 32 32 32 31 33 32 30 32 33 33 32 31 31 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 45 44 47 48 44 46 46 45 38 OFF 48 46 49 50 48 51 52 52 49 49 49 51 48

Pre-Leaching T2 55 - 65 45 46 44 45 44 46 47 52 53 52 45 50 47 46 47 49 48 49 49 50 43 46 45 37

Pre-Leaching T3 45 - 55 61 58 60 62 62 62 20 62 61 59 55 48 50 44 53 53 53 49 50 52 51 55 59 60

Pre-Leaching T4 45 - 55 51 49 45 49 50 50 50 43 37 48 46 43 45 48 42 49 47 50 47 48 45 47 47 46
Date Thursday, November 15, 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 - 130 130 130 124 130 130 130 131 130 130 130 130 130 130 125 130 126 130 130 130 130 130 130 130 130
(L1 – L10)
Main Oven Z3
100 - 130 130 130 130 130 131 128 131 130 131 130 131 131 126 130 130 130 130 130 130 122 130 130 130 130
(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 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 Z6
(L1 – L10 except 100 - 130 129 131 131 131 130 130 OFF 131 130 131 131 132 131 131 131 131 126 131 131 126 130 130 126 131
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
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 67 66 67 68 64 65 65 67 67 68 69 67 67 67 66 62 69 69 64 69 68 67 68

Cooling Tank 3 50 - 70 40 40 37 39 39 40 37 40 40 39 40 40 40 34 41 40 41 41 39 40 37 39 39 40

Cooling Tank 4 40 - 60 56 55 54 56 56 54 55 57 56 54 57 57 51 57 55 57 55 55 53 51 55 54 55 57

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

Chlorine Tank 2 40 - 60 45 45 42 45 48 45 46 47 47 42 47 47 47 46 48 45 45 44 45 47 46 43 46 42

Soak Rinsing
40 - 70 39 40 41 40 41 39 38 41 42 39 43 43 40 42 43 38 40 40 37 39 40 39 37 40
Tank
Post Rinsing
60 - 80 52 50 50 49 51 50 51 48 31 47 52 48 51 50 52 50 48 50 47 48 49 52 51 47
Tank 1
Post Rinsing
60 - 80 41 38 39 22 40 40 38 41 40 40 41 41 36 42 41 42 41 39 40 40 38 41 41 41
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 78 77 77 77 77 77 77 77 77 77 78 78 78 79 79 79 79 79 78 78 78 78 77 72
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44 44

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 Thursday, November 15, 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 63 63 61 64 63 37 61 63 60 54 49 61 58 62 62 64 64 63 66 59 56 62 66 69

Alkaline Tank 1 50 - 70 64 64 64 64 65 62 64 64 63 63 64 61 61 65 65 64 69 68 67 58 55 56 58 64

Alkaline Tank 2 50 - 70 68 65 64 68 68 68 68 68 68 65 68 66 62 68 68 68 69 67 63 59 58 57 59 60

Coagulant Tank 50 - 60 55 54 55 56 56 55 56 56 56 49 56 54 56 55 53 52 57 55 57 53 55 50 53 56

Coagulant Oven 1 100 - 200 118 118 119 123 117 119 111 OFF 119 115 120 118 121 123 125 110 OFF 122 121 122 122 120 121 122

Coagulant Oven 2 100 - 200 115 114 112 115 111 113 115 115 115 108 114 115 112 114 113 102 OFF 58 93 110 110 111 110 110
Former Temp
Before Latex 65 - 75 70 68 69 9 70 67 72 72 69 70 67 69 69 72 69 71 69 72 70 70 72 67 70 68
Tank 1
Latex Tank 1 45 - 55 40 37 37 39 40 39 40 40 39 39 27 24 39 37 38 OFF OFF OFF OFF 38 39 39 37 37

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 43 42 42 43 43 44 43 43 43 43 43 44 45 48 50 51 49 43 39 44 42 43
Tank 2
Latex Tank 2 32 - 36 30 31 32 33 33 33 32 33 31 31 33 33 30 33 32 19 OFF OFF OFF 31 33 31 31 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 52 50 47 49 46 47 49 51 50 48 45 41 38 40 45 47 45 49 53 49 46 45 46 48

Pre-Leaching T2 55 - 65 OFF 42 52 51 52 51 50 49 47 44 47 45 46 45 46 46 47 48 44 45 40 48 48 56

Pre-Leaching T3 45 - 55 65 61 60 60 57 52 51 50 54 58 63 61 62 62 61 57 59 57 57 50 50 47 50 49

Pre-Leaching T4 45 - 55 45 44 44 44 44 45 45 44 44 45 37 47 47 44 48 48 44 48 49 48 46 46 46 45
Date Thursday, November 15, 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 76 111 110 109 111 109 110 109 110 110 111 111 110 111 110 110 71 110 111 110 110 110 110 110
(L1 – L10)
Main Oven Z3
100 - 130 77 114 112 112 112 112 112 111 112 112 112 113 108 112 112 108 74 113 116 108 112 112 112 112
(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 78 109 109 111 110 108 111 111 110 110 110 110 111 110 110 111 71 111 111 111 103 110 110 110
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 OFF 85 111 109 110 110 110 110 109 110 113 111 110 110 110 107 71 111 111 110 103 103 110 110
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 50 50 51 51 49 55 55 55 55 52 54 54 53 53 53 55 48 46 43 49 43 54 55 55

Cooling Tank 3 50 - 70 56 57 58 58 58 58 58 57 57 55 57 57 53 50 50 58 55 53 57 55 55 56 56 52

Cooling Tank 4 40 - 60 54 53 52 52 53 54 53 52 32 50 54 54 52 54 54 51 54 52 51 54 51 55 51 50

Chlorine Tank 1 40 - 60 46 46 44 46 45 43 46 43 45 44 46 46 46 47 34 45 47 47 48 44 45 46 46 46

Chlorine Tank 2 40 - 60 43 44 42 43 41 44 44 38 44 44 44 44 41 43 42 42 43 43 42 40 44 41 43 41

Soak Rinsing
40 - 70 42 42 40 42 43 43 42 43 43 42 43 40 42 43 42 42 41 42 41 41 42 42 42 40
Tank
Post Rinsing
60 - 80 40 40 40 41 41 40 42 OFF 19 38 41 40 38 41 38 37 42 40 41 41 38 41 42 41
Tank 1
Post Rinsing
60 - 80 42 39 37 42 40 42 42 42 42 41 42 43 43 43 43 38 42 41 42 38 37 43 39 37
Tank 2
Final Drying
100 - 130 53 83 84 87 83 81 84 86 80 80 80 77 80 79 84 84 63 83 85 87 76 84 83 86
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) 34 41 42 42 41 41 42 42 42 40 42 41 42 42 42 42 4 42 42 42 42 42 42 42

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 Thursday, November 15, 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 71 68 64 65 68 66 59 OFF 67 62 65 63 60 57 60 61 60 59 58 59 60 57 61 62

Alkaline Tank 1 50 - 70 56 56 55 56 56 57 57 49 41 59 58 35 58 58 56 57 56 58 59 58 57 56 50 52

Alkaline Tank 2 50 - 70 56 56 55 56 56 57 57 49 41 59 58 35 58 58 56 57 56 58 59 58 57 56 50 52

Coagulant Tank 50 - 60 OFF 40 52 54 54 51 54 54 53 52 52 51 53 49 54 53 52 52 55 51 53 55 54 51

Coagulant Oven 1 100 - 200 139 138 135 133 133 135 143 140 139 139 138 136 135 135 135 134 129 131 133 133 133 128 140 140

Coagulant Oven 2 100 - 200 135 132 134 135 141 140 140 136 135 134 127 131 127 129 129 124 127 124 127 127 127 132 134 135
Former Temp
Before Latex 65 - 75 64 63 65 63 72 63 71 74 69 67 64 65 68 68 64 64 65 67 65 59 65 68 69 58
Tank 1
Latex Tank 1 45 - 55 39 37 37 5 37 39 38 40 39 39 39 39 38 36 39 38 39 40 39 39 38 38 39 38

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 49 49 49 46 50 51 50 51 47 46 47 46 46 47 45 46 48 46 47 47 47 46 46 49
Tank 2
Latex Tank 2 32 - 36 32 31 31 32 32 32 31 32 31 30 31 32 32 32 31 30 30 30 31 31 29 30 29 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 52 48 50 50 51 50 57 52 52 51 52 51 52 43 51 50 53 52 50 52 51 50 50 47

Pre-Leaching T2 55 - 65 65 64 61 64 65 66 68 65 61 61 62 60 59 63 49 62 63 58 64 62 59 61 60 56

Pre-Leaching T3 45 - 55 60 58 55 59 55 51 54 59 57 56 57 55 55 52 53 54 54 47 49 50 54 53 51 52

Pre-Leaching T4 45 - 55 46 45 42 45 46 47 48 42 24 47 48 50 48 49 49 49 48 52 50 48 49 48 49 50
Date Thursday, November 15, 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 - 130 110 110 110 110 110 110 111 110 111 110 111 111 110 110 110 110 110 110 110 110 110 110 110 109
(L1 – L10)
Main Oven Z3
100 - 130 112 112 111 111 111 111 115 72 113 113 112 112 111 111 111 111 111 111 111 110 111 111 111 103
(L1 - L10)
Main Oven Z4
100 - 130 OFF 87 111 111 107 111 114 112 112 111 111 111 111 111 112 111 111 111 111 111 111 111 111 112
(L1 - L10)
Main Oven Z5
100 - 130 115 115 114 114 110 110 117 116 118 118 117 117 116 113 111 108 113 112 112 112 111 108 112 113
(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 67 59 63 65 64 68 68 69 66 68 68 63 66 66 66 67 68 68 68 57 57 68 68

Cooling Tank 3 50 - 70 60 57 57 60 57 60 60 61 59 61 61 59 61 57 61 55 60 59 59 61 59 61 59 61

Cooling Tank 4 40 - 60 52 53 47 50 48 47 51 54 55 49 57 57 56 57 55 54 57 53 55 53 57 57 57 57

Chlorine Tank 1 40 - 60 48 48 48 48 48 46 46 46 47 46 27 48 46 46 48 44 49 47 46 47 47 49 46 46

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

Soak Rinsing
40 - 70 44 44 45 44 46 44 41 45 48 48 48 45 44 47 47 45 48 48 45 49 46 48 46 47
Tank
Post Rinsing
60 - 80 44 43 45 43 42 43 41 38 40 39 18 42 45 47 45 48 47 47 47 47 45 39 44 43
Tank 1
Post Rinsing
60 - 80 44 43 44 43 42 42 42 42 40 40 41 41 38 41 47 46 45 48 46 46 46 46 45 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 OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 75 76 41 73 74 74 75 76 76 76 77 77 77 76 76 77 78 78 78 OFF OFF OFF OFF OFF
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 49 49 49 49 49 49 45 48 48 48 47 48 48 48 48 48 48 48 48 48 48 48 48 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 Thursday, November 15, 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 42 38 38 40 42 41 42 41 38 35 38 38 37 40 37 35 36 36 37 36 35 33 34 34

Alkaline Tank 1 50 - 70 46 46 44 47 46 47 48 48 46 46 47 47 47 48 46 48 48 46 45 47 49 44 47 47

Alkaline Tank 2 50 - 70 59 57 56 57 59 34 55 59 55 58 60 35 62 53 47 57 55 59 58 58 58 56 57 54

Coagulant Tank 50 - 60 53 52 50 53 54 54 15 54 42 51 53 53 52 52 47 43 50 49 48 51 49 50 51 53

Coagulant Oven 1 100 - 200 144 143 143 141 143 144 145 142 142 143 143 143 124 OFF 93 143 143 143 143 142 139 139 141 142

Coagulant Oven 2 100 - 200 140 142 142 145 144 142 141 140 141 142 138 143 123 OFF 91 142 142 140 140 139 138 138 138 140
Former Temp
Before Latex 65 - 75 66 64 62 66 68 64 67 68 64 63 65 61 55 50 57 60 64 60 64 58 60 66 67 64
Tank 1
Latex Tank 1 45 - 55 39 37 37 38 39 38 39 38 37 37 37 32 OFF OFF OFF 25 38 36 37 37 39 38 37 38

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 43 44 43 43 43 43 42 41 42 44 48 47 46 43 40 40 42 43 43 41 41 40
Tank 2
Latex Tank 2 32 - 36 32 30 31 31 32 30 32 31 30 31 31 31 30 29 29 30 30 30 29 31 30 31 31 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 56 55 55 56 56 55 55 56 55 54 54 55 59 60 58 56 53 52 54 52 52 49 52 55

Pre-Leaching T2 55 - 65 OFF 54 65 67 67 65 66 66 66 65 44 66 66 71 75 65 65 61 64 64 59 64 63 62

Pre-Leaching T3 45 - 55 63 60 57 62 64 63 63 63 61 60 62 59 65 58 68 64 60 60 60 60 62 61 60 61

Pre-Leaching T4 45 - 55 35 34 34 34 OFF 20 33 33 33 34 29 34 34 32 32 34 33 34 34 33 31 34 32 30
Date Thursday, November 15, 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 - 130 130 130 130 129 130 130 130 130 131 130 129 131 130 OFF 22 114 130 130 130 130 130 130 130 130
(L1 – L10)
Main Oven Z3
100 - 130 131 130 128 130 130 130 130 130 130 130 129 130 126 OFF 37 130 130 130 130 130 130 130 130 130
(L1 - L10)
Main Oven Z4
100 - 130 128 128 128 129 128 128 129 128 129 128 128 127 124 OFF 18 107 118 128 128 129 124 129 129 127
(L1 - L10)
Main Oven Z5
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 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 60 57 60 60 58 57 57 54 60 60 61 60 58 53 57 54 58 58 60 59 53 52 53 53

Cooling Tank 3 50 - 70 58 55 56 57 56 55 55 OFF 28 55 33 59 59 58 53 53 56 55 52 58 56 57 49 56

Cooling Tank 4 40 - 60 54 53 54 26 54 53 50 53 55 55 55 55 55 54 52 49 47 49 49 49 51 52 48 48

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

Chlorine Tank 2 40 - 60 43 43 40 45 45 45 45 45 46 43 46 44 44 44 45 44 38 39 40 41 44 44 44 44

Soak Rinsing
40 - 70 43 43 42 43 44 44 43 44 45 44 45 44 45 42 44 43 42 42 42 40 40 42 43 39
Tank
Post Rinsing
60 - 80 41 41 40 42 42 42 42 42 43 40 43 42 42 43 42 40 42 41 38 41 41 38 42 34
Tank 1
Post Rinsing
60 - 80 60 64 63 66 61 62 66 62 66 66 66 64 61 47 52 57 63 60 65 65 65 63 61 65
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 70 70 70
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 Thursday, November 15, 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 15 14 14 14 13 14 14 12 11 10 12 14 13 8 4 1 1012 1208 908 984 856 856 841 841

Alkaline Tank 1 50 - 70 32 32 32 32 32 33 33 33 32 31 33 34 36 36 37 38 38 37 38 37 36 36 35 34

Alkaline Tank 2 50 - 70 34 34 33 34 34 34 33 33 32 32 34 35 36 37 38 39 39 38 38 38 37 36 34 35

Coagulant Tank 50 - 60 34 34 34 34 32 34 34 34 34 34 34 34 33 34 34 33 34 34 34 33 34 35 35 35

Coagulant Oven 1 100 - 200 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Coagulant Oven 2 100 - 200 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Former Temp
Before Latex 65 - 75 47 46 45 45 46 46 46 47 47 47 48 49 50 47 48 51 51 52 52 50 51 51 49 49
Tank 1
Latex Tank 1 45 - 55 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

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 42 43 43 42 41 41 41 41 42 42 42 40 43 43 42 44 42 44 42 42 41 44
Tank 2
Latex Tank 2 32 - 36 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

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 41 42 43 43 43 44 45 45 45 44 43 45 44 45 45 45 46 46 46 47 46 46 47 46

Pre-Leaching T2 55 - 65 40 40 40 40 40 41 41 42 41 42 43 44 42 42 43 44 44 44 44 45 43 44 45 44

Pre-Leaching T3 45 - 55 41 40 40 40 40 41 42 42 41 42 43 43 43 44 44 44 45 42 45 45 44 43 44 43

Pre-Leaching T4 45 - 55 42 42 42 41 42 42 43 42 42 42 43 44 46 46 46 47 47 48 47 45 46 46 46 45
Date Thursday, November 15, 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 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 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 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 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 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
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 43 43 43 42 42 41 40 40 40 41 41 40 40 43 30 42 44 45 44 44 43 42 40 40

Cooling Tank 3 50 - 70 39 40 41 40 40 39 39 38 38 38 39 38 36 40 39 41 42 41 41 42 40 40 40 34

Cooling Tank 4 40 - 60 40 40 40 39 40 40 40 40 41 40 42 40 39 39 40 40 39 35 40 38 39 38 39 37

Chlorine Tank 1 40 - 60 43 43 43 43 43 42 41 41 40 40 41 41 41 42 43 43 44 44 45 45 45 40 42 42

Chlorine Tank 2 40 - 60 42 42 42 42 40 41 41 41 40 40 41 41 40 42 43 44 42 43 44 44 43 42 41 42

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 46 46 45 45 44 44 43 43 43 42 43 43 43 45 45 46 47 48 47 47 46 46 43 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 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 Thursday, November 15, 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 44 44 40 43 44 42 44 44 42 44 47 49 49 49 48 49 49 47 45 43 40 42 43 41

Alkaline Tank 1 50 - 70 40 41 41 41 41 41 41 41 40 41 44 46 49 47 50 48 46 47 44 42 44 44 40 43

Alkaline Tank 2 50 - 70 40 39 39 41 41 41 41 41 41 42 45 48 49 53 53 50 48 45 41 41 38 43 43 41

Coagulant Tank 50 - 60 54 54 54 55 55 54 55 54 44 52 52 51 47 51 52 51 52 53 50 52 52 53 50 51

Coagulant Oven 1 100 - 200 124 122 120 120 123 122 121 120 121 122 124 121 120 118 120 120 118 114 118 119 119 120 120 108

Coagulant Oven 2 100 - 200 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF
Former Temp
Before Latex 65 - 75 57 55 58 59 57 56 59 60 59 58 52 58 59 57 59 60 57 58 57 57 56 57 59 52
Tank 1
Latex Tank 1 45 - 55 41 40 39 40 40 34 38 40 39 39 38 39 41 39 41 40 40 41 40 40 42 40 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 OFF 33 40 41 42 41 40 36 29 38 42 40 38 40 40 40 41 40 40 40 42 40 41 42
Tank 2
Latex Tank 2 32 - 36 34 34 33 35 OFF 21 34 35 34 33 34 34 33 33 33 34 32 33 34 33 33 33 33 34

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 45 41 60 58 58 61 OFF 35 40 OFF 22 44 34 48 42 44 41 41 40 46 42 44 46

Pre-Leaching T2 55 - 65 73 70 72 72 73 72 75 73 70 70 74 74 72 71 72 69 72 71 71 71 71 70 68 73

Pre-Leaching T3 45 - 55 48 47 48 50 51 52 53 31 60 55 30 32 51 44 48 51 49 52 54 55 51 51 50 50

Pre-Leaching T4 45 - 55 53 56 53 56 58 58 60 54 42 57 58 59 57 57 54 53 52 51 52 51 50 52 51 52
Date Thursday, November 15, 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 - 130 126 126 125 126 126 124 126 127 125 125 127 125 125 125 126 125 125 125 125 125 125 126 125 125
(L1 – L10)
Main Oven Z3
100 - 130 123 121 124 124 124 122 125 125 123 124 126 123 124 124 123 124 124 124 124 124 124 123 124 115
(L1 - L10)
Main Oven Z4
100 - 130 117 116 113 116 118 118 118 119 118 117 118 114 115 115 114 113 108 108 111 113 115 111 117 117
(L1 - L10)
Main Oven Z5
100 - 130 124 123 125 125 124 124 125 125 125 125 125 124 125 125 125 125 125 125 125 125 125 125 125 124
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 122 120 119 121 122 122 121 121 121 122 123 122 118 122 122 122 123 122 122 122 122 122 121
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 58 58 56 58 59 59 57 57 59 56 58 57 55 57 53 57 57 59 57 59 59 49 57 59

Cooling Tank 3 50 - 70 57 55 55 56 56 55 56 54 57 50 56 56 54 54 56 56 52 56 56 56 56 52 56 56

Cooling Tank 4 40 - 60 50 51 51 52 50 51 49 47 51 49 51 51 51 50 36 49 52 50 50 51 47 51 51 43

Chlorine Tank 1 40 - 60 45 41 44 24 46 44 45 45 44 40 44 43 42 44 45 46 46 43 48 48 45 44 43 46

Chlorine Tank 2 40 - 60 44 42 42 43 45 45 42 45 45 44 45 45 40 42 43 44 41 43 44 44 45 45 45 42

Soak Rinsing
40 - 70 52 52 53 54 51 49 54 50 53 52 53 51 54 54 54 48 53 55 52 53 50 54 47 50
Tank
Post Rinsing
60 - 80 40 40 38 40 40 39 39 40 40 37 40 40 40 40 40 35 40 40 40 39 37 33 36 36
Tank 1
Post Rinsing
60 - 80 36 36 38 38 38 39 OFF 38 38 38 16 38 37 38 38 37 35 38 38 38 37 39 36 39
Tank 2
Final Drying
100 - 130 68 69 70 64 52 41 40 66 67 68 68 69 71 71 72 72 74 75 75 OFF OFF 72 OFF 61
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 Thursday, November 15, 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 60 58 56 58 58 58 58 58 58 57 57 55 56 58 57 57 58 59 58 59 56 57 58 52

Alkaline Tank 1 45 - 75 64 64 61 62 55 52 50 50 51 61 63 63 63 64 64 65 63 64 61 65 62 63 65 63

Alkaline Tank 2 45 - 75 61 58 59 59 54 49 49 27 48 55 64 63 63 63 62 63 63 61 57 55 55 55 53 51

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

Coagulant Oven 1 100 - 200 123 124 125 125 127 126 126 127 127 126 126 125 126 126 121 121 121 120 119 119 117 119 120 124

Coagulant Oven 2 100 - 200 121 123 124 123 127 126 114 65 126 124 126 126 126 124 121 123 123 121 119 121 121 121 119 124
Former Temp
Before Latex 60 - 75 58 57 57 58 58 57 57 52 58 58 59 60 60 60 60 61 62 61 60 59 57 56 57 59
Tank 1
Latex Tank 1 40 - 55 41 39 41 39 41 41 41 39 40 39 42 42 42 39 41 41 42 41 41 41 41 41 37 38

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 41 40 41 40 40 37 38 39 39 41 40 41 41 41 41 41 40 41 41 40 39 40
Tank 2
Latex Tank 2 30 - 36 34 34 33 34 34 34 34 33 34 34 34 33 33 34 33 33 34 33 33 33 34 33 33 34

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 50 - 65 47 46 43 46 45 44 43 43 44 41 40 41 40 40 41 42 42 42 44 44 46 44 50 50

Pre-Leaching T2 50 - 65 55 54 54 55 55 53 54 54 47 53 54 54 53 53 53 52 51 52 52 51 53 52 55 59

Pre-Leaching T3 45 - 65 47 47 47 47 47 47 43 OFF 48 45 47 47 46 46 45 46 46 46 45 46 46 46 50 46

Pre-Leaching T4 40 - 65 52 51 51 52 52 52 51 51 53 51 51 50 51 51 51 50 50 51 51 50 49 49 54 55
Date Thursday, November 15, 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 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 Z3
100 - 130 118 117 119 117 119 119 119 118 119 119 119 117 119 119 83 115 119 119 119 119 119 119 120 119
(L1 - L10)
Main Oven Z4
100 - 130 121 116 120 121 116 119 121 120 120 120 120 119 120 120 116 120 120 116 120 120 120 112 121 120
(L1 - L10)
Main Oven Z5
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 Z6
(L1 – L10 except 100 - 130 120 121 121 121 117 121 121 121 OFF OFF OFF OFF 88 113 120 121 121 121 121 121 121 121 122 113
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 66 65 66 64 66 64 56 66 64 62 61 59 61 59 63 63 67 62 66 64 66 64 68 69

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

Cooling Tank 4 40 - 60 59 59 57 58 58 58 58 58 55 57 56 55 53 55 57 56 57 59 59 59 59 57 59 59

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 47 47 48 48 48 48 48 47 22 48 48 47 45 40 45 46 45 46 45 46 48 42 46 48

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 50 50 51 51 51 51 51 52 52 49 51 49 47 51 51 52 51 52 52 52 52 51 50 48
Tank 1
Post Rinsing
40 - 80 45 45 45 45 45 45 45 45 45 43 44 44 44 44 44 44 45 45 45 45 42 45 45 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) 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 Thursday, November 15, 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 55 55 52 53 55 53 54 54 54 53 54 32 56 53 57 57 59 55 57 54 58 55 57 53

Alkaline Tank 1 45 - 75 61 60 56 61 60 37 OFF 59 58 58 61 59 59 63 63 62 58 63 60 60 61 61 60 63

Alkaline Tank 2 45 - 75 53 51 51 53 53 52 52 51 50 45 45 44 43 45 45 44 46 37 47 51 53 52 54 52

Coagulant Tank 45 - 60 52 52 49 52 51 52 52 51 51 48 50 48 49 51 48 49 48 49 51 50 49 47 49 45

Coagulant Oven 1 100 - 200 146 146 147 147 144 146 145 146 144 147 148 148 149 149 149 146 148 143 145 145 148 147 144 148

Coagulant Oven 2 100 - 200 145 143 145 146 143 145 146 145 143 145 145 146 146 147 144 147 141 140 143 145 140 145 146 146
Former Temp
Before Latex 65 - 75 69 65 66 68 63 66 66 70 55 65 66 67 68 68 69 71 66 71 71 65 68 69 69 68
Tank 1
Latex Tank 1 40 - 55 41 40 40 41 41 41 41 41 40 40 40 40 40 38 40 40 41 38 38 39 39 38 39 38

Latex Oven 1
36 - 40 45 44 43 44 44 43 43 43 43 43 44 44 44 45 46 46 46 46 45 45 44 44 45 46
Temp
Former Temp
Before Latex 50 - 150 39 39 37 39 40 38 38 38 37 36 38 39 36 39 40 39 38 38 39 37 37 37 36 39
Tank 2
Latex Tank 2 30 - 36 30 30 29 30 30 31 32 31 31 32 30 30 28 30 29 29 28 30 28 30 31 29 30 30

Latex Oven 2
100 - 130 129 126 128 130 129 127 126 125 128 128 126 127 129 129 127 128 128 129 124 126 128 128 126 129
Temp

Pre-Leaching T1 55 - 65 62 58 62 62 60 62 62 62 60 57 62 62 61 56 61 56 60 58 59 62 60 58 58 59

Pre-Leaching T2 55 - 65 OFF 51 66 69 OFF 41 68 68 68 67 68 66 65 68 63 65 66 65 65 64 64 66 68 67

Pre-Leaching T3 45 - 65 55 52 53 7 55 55 55 54 54 51 53 52 50 46 52 54 52 51 52 51 52 52 50 55

Pre-Leaching T4 45 - 65 50 48 48 48 47 42 41 42 40 39 42 43 42 44 44 43 43 43 44 43 40 40 43 48
Date Thursday, November 15, 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 - 130 117 117 118 116 119 119 120 119 119 120 119 119 120 120 120 120 116 120 116 120 120 120 116 120
(L1 – L10)
Main Oven Z3
100 - 130 119 119 113 120 119 119 112 119 118 119 118 120 119 119 115 119 119 119 119 115 119 119 119 120
(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 - 130 122 122 122 122 123 120 122 122 122 117 122 122 122 122 122 122 123 123 123 123 123 115 123 123
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 118 118 119 120 118 120 120 120 120 120 119 120 120 120 116 116 116 120 120 120 108 120 120
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
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 62 62 64 61 64 64 62 64 63 62 63 62 62 63 63 59 62 60 60 62 64 64 62 58

Cooling Tank 3 50 - 70 58 57 56 56 58 59 58 48 58 56 58 56 52 52 46 57 60 58 55 57 60 56 53 55

Cooling Tank 4 40 - 60 54 53 49 52 54 53 54 51 53 49 53 53 49 49 53 49 50 52 50 50 45 53 54 54

Chlorine Tank 1 40 - 60 49 49 49 49 48 49 50 50 49 46 49 49 49 47 34 47 44 50 47 48 48 50 45 50

Chlorine Tank 2 40 - 60 50 49 47 48 48 47 50 49 46 45 49 50 47 48 37 50 52 51 50 49 51 52 51 45

Soak Rinsing
40 - 70 77 75 77 78 76 78 76 78 78 75 78 78 75 70 78 75 74 79 76 79 79 79 68 79
Tank
Post Rinsing
40 - 80 44 42 43 43 42 42 41 44 43 40 43 43 42 42 40 41 43 44 41 43 41 41 44 44
Tank 1
Post Rinsing
40 - 80 42 42 43 44 42 44 44 44 44 43 44 41 42 44 41 44 41 42 42 42 44 45 44 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) 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: Thursday, November 15, 2018

Line Production
1 852049
2 822349
3 718700
4 312106
5 842621
6 72585
7 0
8 0
9 0
10 0

TOTAL ALL: 3620410

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