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GMP MEDICARE SDN.

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

Date Thursday, October 04, 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 46 47 48 49 48 49 49 49 50 48 51 49 52 51 52 52 53 54 52 52 53 51 50 51

Alkaline Tank 1 50 - 70 63 61 62 63 60 60 62 61 60 61 60 63 62 64 65 64 64 66 65 64 62 62 64 64

Alkaline Tank 2 50 - 70 67 69 67 69 68 69 69 66 66 64 67 68 69 68 69 70 70 70 71 69 70 66 70 68

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

Coagulant Oven 1 100 - 200 148 151 144 153 154 154 149 154 151 154 154 154 149 144 138 140 140 140 133 132 130 128 133 134

Coagulant Oven 2 100 - 200 144 147 145 148 150 147 150 150 145 150 149 149 147 140 136 136 136 136 131 129 129 129 129 132
Former Temp
Before Latex 65 - 75 62 67 67 67 67 67 67 67 67 68 69 67 70 69 69 65 70 68 67 67 67 66 66 65
Tank 1
Latex Tank 1 45 - 55 37 41 41 40 41 42 41 40 40 42 42 42 43 42 42 43 42 42 42 42 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 44 43 42 43 42 41 40 42 40 44 44 44 46 46 47 45 48 47 45 45 46 45 44 43
Tank 2
Latex Tank 2 32 - 36 32 33 32 33 32 32 33 32 33 32 33 33 33 33 33 33 32 32 33 33 31 33 33 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 47 48 48 50 50 48 49 48 48 49 49 50 50 50 50 52 53 52 52 51 50 52 51 50

Pre-Leaching T2 55 - 65 47 45 47 60 67 59 48 51 36 38 56 62 60 66 65 66 67 66 67 66 65 60 58 64

Pre-Leaching T3 45 - 55 44 47 51 52 51 52 50 47 45 46 45 46 47 46 48 47 48 47 48 48 46 47 50 49

Pre-Leaching T4 45 - 55 37 38 38 39 39 39 38 38 37 38 39 40 42 42 41 44 44 44 43 43 41 40 39 38
Date Thursday, October 04, 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 - 130 115 113 113 115 113 113 115 115 115 115 115 114 114 114 114 114 110 114 114 111 114 114 111 111
(L1 – L10)
Main Oven Z3
100 - 130 102 116 116 114 114 116 116 116 116 112 116 112 116 112 116 116 116 116 116 116 116 112 112 116
(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 - 130 116 118 120 120 118 120 120 120 120 120 120 120 120 120 120 120 120 121 120 120 120 116 120 116
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 120 120 120 120 120 120 118 116 115 117 117 119 119 120 115 120 120 120 120 120 120 116 116
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
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 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 56 57 59 59 58 58 59 58 56 56 57 55 58 56 58 60 61 60 61 58 56 58 59 60

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 40 46 44 45 43 43 42 42 40 43 40 43 44 45 45 45 46 46 44 44 43 42 41 41

Chlorine Tank 2 40 - 60 41 42 42 43 42 43 42 43 45 42 38 39 40 39 39 39 40 40 41 41 40 39 40 37

Soak Rinsing
40 - 70 36 38 39 39 38 40 38 40 41 40 39 38 37 38 35 39 39 39 39 38 39 39 39 39
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 39 39 39 40 39 40 40 37 40 41 40 40 39 40 40 40 40 40 41 41 39 39 40 40
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) 39 43 43 44 44 43 44 44 43 45 45 45 45 45 45 45 45 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 Thursday, October 04, 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 58 60 63 64 63 64 64 62 63 60 59 59 62 64 65 65 64 64 63 64 64 62 63 64

Alkaline Tank 1 50 - 70 57 61 63 62 62 62 63 62 60 61 58 56 61 62 62 63 65 66 65 65 65 65 62 55

Alkaline Tank 2 50 - 70 60 65 67 68 67 67 68 67 67 65 64 61 62 63 64 63 63 65 64 61 61 61 61 56

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

Coagulant Oven 1 100 - 200 121 121 121 121 119 119 121 121 118 121 120 120 121 120 119 OFF 95 119 119 119 119 119 115 116

Coagulant Oven 2 100 - 200 119 117 117 117 119 119 119 119 113 119 117 117 117 118 117 OFF 96 117 113 117 115 115 112 112
Former Temp
Before Latex 65 - 75 58 59 59 59 56 57 59 55 56 60 59 61 61 61 58 53 58 62 59 61 61 61 53 54
Tank 1
Latex Tank 1 45 - 55 43 44 45 44 43 42 43 41 42 42 44 43 44 44 42 38 38 42 42 45 47 48 46 42

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 42 40 41 41 38 39 40 39 42 43 44 43 42 47 49 46 44 45 44 44 44 45 42
Tank 2
Latex Tank 2 32 - 36 36 36 36 35 36 35 35 34 35 34 34 36 36 36 36 35 33 36 36 36 36 37 36 35

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 54 54 51 53 53 49 44 39 39 48 51 51 51 52 55 56 53 52 53 53 53 53 52 51

Pre-Leaching T2 55 - 65 54 51 49 50 49 48 48 48 46 48 60 63 64 67 66 68 72 70 68 67 67 64 68 70

Pre-Leaching T3 45 - 55 51 51 51 52 53 53 49 44 42 48 57 61 62 61 59 62 61 56 50 56 59 58 61 64

Pre-Leaching T4 45 - 55 50 41 40 39 40 38 39 39 39 41 45 47 46 47 47 46 46 48 47 46 45 45 45 43
Date Thursday, October 04, 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 - 130 119 119 120 116 121 120 119 119 120 120 120 116 120 120 116 OFF 62 120 116 120 116 121 121 121
(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 - 130 121 121 117 121 119 119 121 121 121 121 121 121 121 121 117 OFF 79 117 121 121 121 121 121 117
(L1 - L10)
Main Oven Z5
100 - 130 118 117 120 118 120 116 120 120 112 120 120 120 120 120 120 OFF 78 120 120 120 116 120 120 117
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 116 116 120 120 120 118 120 120 120 120 120 120 120 120 120 OFF 77 120 120 120 120 120 120 120
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
N/A - N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 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 64 69 72 71 71 73 72 73 70 72 66 71 71 75 75 72 64 71 72 70 69 72 74 67

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 47 51 49 51 51 49 48 49 49 47 48 48 50 52 52 50 50 53 53 52 50 50 46 47

Chlorine Tank 2 40 - 60 35 39 41 41 43 43 45 45 52 46 40 39 39 40 40 37 35 38 39 40 40 39 40 40

Soak Rinsing
40 - 70 36 38 40 39 40 42 41 42 44 41 42 40 39 37 40 40 37 39 40 40 39 40 40 41
Tank
Post Rinsing
60 - 80 47 48 47 46 45 46 45 45 44 44 44 45 46 47 48 49 49 49 49 49 48 44 45 46
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 - 130 135 138 138 138 137 138 138 135 137 138 138 138 138 138 138 OFF 80 134 138 133 138 138 133 138
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 42 43 41 43 43 43 43 43 43 43 43 42 42 41 10 28 43 43 43 42 43 43 41

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, October 04, 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 60 60 61 60 61 61 60 60 59 61 61 59 62 62 63 66 65 64 62 63 62 62 63

Alkaline Tank 1 50 - 70 65 64 63 64 64 63 62 63 63 60 59 61 61 58 62 66 68 67 67 65 64 64 66 66

Alkaline Tank 2 50 - 70 65 64 64 65 65 63 64 64 64 62 61 59 60 57 58 64 67 67 66 68 66 64 66 67

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

Coagulant Oven 1 100 - 200 119 117 119 117 119 117 119 117 117 119 119 117 OFF OFF 114 117 119 116 118 117 117 113 117 115

Coagulant Oven 2 100 - 200 119 119 121 119 120 118 120 120 121 119 117 120 OFF OFF 111 118 120 116 116 116 117 116 114 116
Former Temp
Before Latex 65 - 75 70 68 68 67 70 69 70 69 68 70 70 71 68 64 69 71 70 71 73 72 67 70 71 67
Tank 1
Latex Tank 1 45 - 55 40 39 39 39 40 39 39 40 40 40 40 40 OFF OFF 21 39 39 40 38 39 38 38 37 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 41 41 41 39 41 40 41 41 41 42 43 43 46 45 44 42 42 41 42 41 41 41 40 41
Tank 2
Latex Tank 2 32 - 36 32 33 32 33 33 33 32 33 32 32 31 33 32 32 32 31 32 32 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 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 44 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF

Pre-Leaching T2 55 - 65 50 50 49 49 51 55 56 52 52 54 55 57 57 54 48 46 48 47 45 48 54 50 46 44

Pre-Leaching T3 45 - 55 64 62 62 61 62 63 62 63 63 62 61 61 59 57 57 61 62 61 61 57 57 58 56 60

Pre-Leaching T4 45 - 55 54 52 53 52 52 50 52 51 54 53 53 54 53 51 48 49 53 53 52 53 50 50 51 51
Date Thursday, October 04, 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 - 130 108 109 109 109 109 108 110 108 110 109 105 108 108 OFF 80 108 110 109 109 106 106 102 110 110
(L1 – L10)
Main Oven Z3
100 - 130 109 111 109 109 109 109 111 111 111 111 111 111 111 OFF 68 82 111 111 111 111 111 107 111 111
(L1 - L10)
Main Oven Z4
100 - 130 109 107 110 110 108 111 108 110 110 110 110 107 111 OFF 105 107 111 107 111 111 110 111 111 111
(L1 - L10)
Main Oven Z5
100 - 130 117 114 113 114 114 114 112 114 113 114 113 115 115 OFF 108 113 115 119 116 112 114 114 116 114
(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 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 30 43 43 42 46 47 46 49 48 44 44 43 44 45

Cooling Tank 3 50 - 70 38 38 39 38 38 38 40 40 40 40 40 39 38 38 37 37 35 37 38 38 38 37 37 37

Cooling Tank 4 40 - 60 39 40 39 40 39 39 40 40 43 40 37 36 37 36 33 35 36 37 37 36 36 36 37 37

Chlorine Tank 1 40 - 60 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 51 52 52 52 51 49 46 43

Chlorine Tank 2 40 - 60 38 37 40 39 39 39 40 40 44 39 35 34 33 31 32 33 32 33 34 33 34 34 34 34

Soak Rinsing
40 - 70 63 64 63 60 61 59 62 61 59 61 111 61 62 61 58 59 62 65 63 64 57 63 63 63
Tank
Post Rinsing
60 - 80 54 52 54 54 53 53 53 52 50 52 52 50 50 51 47 48 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 43 53 53 51 53 52 54 53
Tank 2
Final Drying
100 - 130 OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF OFF 95 130 OFF OFF OFF OFF OFF OFF OFF OFF
Oven Z1
Final Drying
100 - 130 129 131 129 131 131 129 131 131 127 127 131 127 127 OFF OFF OFF 45 131 131 131 123 127 131 131
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 43 43 43 43 43 43 43 43 43 43 43 43 39 OFF 40 41 42 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 Thursday, October 04, 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 51 49 51 49 51 50 51 50 52 62 65 69 73 74 69 70 72 70 69 71 69 68 62 57

Alkaline Tank 1 50 - 70 56 58 58 54 58 57 58 58 57 59 60 58 42 58 65 67 66 67 67 65 63 65 64 63

Alkaline Tank 2 50 - 70 61 61 61 62 63 63 63 62 63 62 63 62 53 42 52 66 69 68 65 65 64 64 64 62

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

Coagulant Oven 1 100 - 200 125 125 125 125 125 123 123 123 123 121 123 110 125 124 124 122 124 121 123 123 121 121 123 123

Coagulant Oven 2 100 - 200 123 123 121 123 123 122 122 122 121 119 121 109 120 119 121 119 121 119 121 121 122 117 120 118
Former Temp
Before Latex 65 - 75 73 74 74 73 72 72 72 71 70 73 70 67 73 74 74 74 75 76 75 75 73 73 73 73
Tank 1
Latex Tank 1 45 - 55 40 42 42 42 43 44 44 43 43 43 40 40 40 41 42 42 43 43 43 43 43 43 44 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 44 46 46 46 45 45 46 46 44 48 53 49 44 47 47 47 47 47 47 46 46 46 46
Tank 2
Latex Tank 2 32 - 36 33 33 34 33 33 33 34 33 34 33 33 32 33 34 33 33 34 33 33 34 33 33 33 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 45 46 46 44 44 44 44 44 43 45 49 47 45 44 43 41 44 44 44 43 43 43 42

Pre-Leaching T2 55 - 65 43 45 45 45 48 52 57 57 58 56 56 58 64 58 57 55 56 55 56 54 53 55 55 50

Pre-Leaching T3 45 - 55 45 46 46 44 45 47 51 52 51 51 52 51 56 58 66 65 64 59 58 56 56 55 50 46

Pre-Leaching T4 45 - 55 46 47 47 47 48 53 62 66 67 64 66 67 70 68 66 66 65 64 65 63 65 65 60 51
Date Thursday, October 04, 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 - 130 126 126 119 123 125 125 123 125 126 125 125 122 127 126 126 126 126 125 126 125 121 126 126 125
(L1 – L10)
Main Oven Z3
100 - 130 123 123 123 125 125 125 125 126 126 126 121 126 126 121 126 121 126 125 125 126 125 125 126 126
(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 - 130 125 123 123 121 125 125 125 123 125 125 121 125 124 126 125 125 125 121 125 121 125 125 121 125
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 122 124 124 124 124 122 122 122 120 124 124 125 73 124 124 124 120 124 125 120 124 124 124 120
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 53 56 56 55 53 54 53 52 49 48 52 57 48 48 57 58 57 59 59 58 57 56 56 54

Cooling Tank 3 50 - 70 72 72 72 73 73 73 73 74 75 75 71 71 66 68 71 73 71 72 74 71 70 72 72 73

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 51 51 50 50 51 51 50 51 51 49 52 53 47 49 51 50 51 52 51 51 49 52 50 51

Chlorine Tank 2 40 - 60 48 49 49 52 52 50 51 52 52 52 52 50 50 49 48 49 49 50 49 51 49 51 50 52

Soak Rinsing
40 - 70 48 48 47 47 48 49 49 49 49 46 49 49 48 47 47 46 48 46 46 49 47 47 49 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 - 130 124 117 121 122 120 118 120 121 116 117 116 117 131 128 116 120 122 121 123 123 123 113 118 128
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 35 39 40 44 44 44 44 44 44 44 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, October 04, 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 53 53 53 51 54 56 56 58 62 67 67 63 62 64 62 66 68 65 70 63 65 65 65 70

Alkaline Tank 1 50 - 70 57 55 53 54 52 53 57 55 54 54 51 51 52 53 54 55 53 55 53 55 53 50 49 54

Alkaline Tank 2 50 - 70 57 55 53 54 52 53 57 55 54 54 51 51 52 53 54 55 53 55 53 55 53 50 49 54

Coagulant Tank 50 - 60 54 53 51 48 53 53 52 53 52 51 47 54 51 50 52 50 51 53 52 52 51 50 51 52

Coagulant Oven 1 100 - 200 149 149 149 149 149 145 142 141 146 149 144 149 149 147 147 146 144 142 144 142 144 144 144 144

Coagulant Oven 2 100 - 200 141 144 141 141 144 138 140 139 142 144 144 142 142 144 144 140 137 137 139 139 139 139 139 139
Former Temp
Before Latex 65 - 75 366 360 360 360 354 366 366 366 373 366 373 379 373 360 373 354 354 360 360 366 373 353 366 360
Tank 1
Latex Tank 1 45 - 55 38 38 37 41 38 39 40 42 41 40 40 42 41 39 41 43 40 40 41 42 41 41 40 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 49 49 50 49 48 48 50 47 46 49 50 47 51 50 50 50 47 50 49 47 51 47 49 49
Tank 2
Latex Tank 2 32 - 36 31 33 32 32 32 33 33 32 32 32 32 32 31 33 34 33 33 30 32 32 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 38 40 40 41 40 44 45 46 45 41 43 46 45 47 49 43 40 43 43 44 45 45 46 43

Pre-Leaching T2 55 - 65 51 51 50 50 51 52 52 50 50 52 49 53 54 53 54 55 56 54 51 49 45 44 49 51

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

Pre-Leaching T4 45 - 55 49 46 46 49 47 48 47 46 47 48 49 49 50 51 50 52 52 49 49 51 50 53 51 48
Date Thursday, October 04, 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 - 130 125 122 124 124 125 126 126 125 120 125 124 124 124 124 124 124 124 124 124 124 124 126 123 127
(L1 – L10)
Main Oven Z3
100 - 130 126 124 124 121 126 124 126 128 126 126 126 126 126 126 126 126 122 126 126 126 126 130 131 131
(L1 - L10)
Main Oven Z4
100 - 130 123 125 123 125 125 127 127 127 125 125 125 121 125 125 125 121 121 125 121 125 125 130 130 130
(L1 - L10)
Main Oven Z5
100 - 130 124 126 126 124 126 128 129 128 126 126 126 126 126 126 126 126 126 126 126 122 126 131 131 131
(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 68 68 66 68 68 66 70 66 66 59 66 68 66 64 69 65 69 67 64 64 67 67 69 66

Cooling Tank 3 50 - 70 59 65 60 66 64 66 64 66 66 64 64 61 63 66 61 62 64 67 67 64 64 59 66 68

Cooling Tank 4 40 - 60 56 57 58 56 58 57 59 56 58 54 60 60 58 58 59 57 57 61 61 59 59 61 58 58

Chlorine Tank 1 40 - 60 41 41 42 40 43 41 43 43 48 38 36 36 37 37 36 33 35 36 33 36 35 36 37 35

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

Soak Rinsing
40 - 70 56 59 56 56 56 56 50 53 55 54 51 51 54 60 61 60 60 57 61 61 59 57 56 50
Tank
Post Rinsing
60 - 80 42 41 44 44 44 43 42 41 39 40 40 43 41 46 46 46 50 47 47 47 49 45 44 44
Tank 1
Post Rinsing
60 - 80 69 71 69 71 68 70 71 73 71 68 70 69 69 71 61 66 62 70 72 71 64 69 67 70
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 93 91 93 92 92 93 93 91 88 91 92 93 93 94 94 95 94 94 94 90 90 94 91 95
Oven Z2

Wash Filter

Latex Compounding Tank

Line Speed (Hz) 53 54 54 54 54 54 51 54 54 54 54 53 53 54 54 54 54 52 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 Thursday, October 04, 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 59 55 54 57 56 55 58 57 57 58 57 55 58 57 58 57 57 57 57 59 58 58 59 55

Alkaline Tank 1 50 - 70 48 49 50 48 48 47 47 48 49 45 50 48 48 47 48 47 47 48 49 49 50 47 52 48

Alkaline Tank 2 50 - 70 63 64 62 60 61 62 60 62 62 62 62 65 62 65 66 63 66 59 63 62 62 63 64 64

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

Coagulant Oven 1 100 - 200 148 148 148 147 145 145 140 148 148 147 146 144 144 147 144 OFF OFF 126 145 146 144 144 146 147

Coagulant Oven 2 100 - 200 144 144 142 144 144 142 144 142 145 144 144 144 144 141 144 OFF OFF 136 140 143 141 141 141 144
Former Temp
Before Latex 65 - 75 66 63 62 64 62 66 64 62 66 67 65 65 68 68 69 58 58 61 66 68 64 66 64 65
Tank 1
Latex Tank 1 45 - 55 41 39 42 42 40 41 40 40 39 41 43 40 44 43 44 33 OFF OFF 41 45 43 42 43 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 42 44 42 44 43 44 45 44 44 42 43 45 44 44 42 49 48 48 45 44 44 43 46 44
Tank 2
Latex Tank 2 32 - 36 35 31 33 34 34 34 32 33 34 34 34 34 33 32 32 32 34 34 33 33 33 34 33 35

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 32 30 31 31 33 32 33 33 33 32 31 32 33 34 31 34 36 34 36 43 41 46 49 47

Pre-Leaching T2 55 - 65 64 59 60 61 57 58 55 52 49 48 46 44 42 44 45 49 50 47 44 45 41 42 44 46

Pre-Leaching T3 45 - 55 58 55 57 58 56 56 56 57 54 57 56 52 55 50 52 56 55 52 51 50 55 55 50 55

Pre-Leaching T4 45 - 55 38 40 37 41 40 43 40 42 44 43 44 45 45 45 42 41 42 41 44 42 41 43 44 42
Date Thursday, October 04, 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 56 103 103 100 103 106 106 106 106 106 106 102 106 106 106 OFF OFF 106 105 102 105 106 106 106
(L1 – L10)
Main Oven Z3
100 - 130 56 104 100 99 104 115 115 117 117 113 117 119 119 120 119 OFF OFF 108 104 99 105 114 117 117
(L1 - L10)
Main Oven Z4
100 - 130 54 101 102 100 102 105 105 105 98 105 101 105 105 105 105 OFF OFF 101 105 104 105 105 105 105
(L1 - L10)
Main Oven Z5
100 - 130 56 87 81 78 83 101 102 100 101 79 101 101 101 101 101 OFF OFF 77 68 66 87 98 102 98
(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 53 54 53 55 56 60 62 63 60 59 54 63 61 57 58 57 55 52 59 61 61 63 63 62

Cooling Tank 3 50 - 70 56 55 56 57 54 54 58 61 56 56 56 57 60 57 61 61 58 51 55 54 57 55 64 62

Cooling Tank 4 40 - 60 49 48 50 47 52 52 54 52 49 54 53 55 55 52 55 50 48 44 46 53 50 55 58 56

Chlorine Tank 1 40 - 60 45 48 47 47 47 45 46 47 42 47 49 46 48 50 51 50 47 46 44 48 46 47 48 49

Chlorine Tank 2 40 - 60 35 38 39 40 40 41 41 40 44 40 37 35 35 37 36 36 30 32 34 32 35 34 32 35

Soak Rinsing
40 - 70 42 40 39 41 41 41 42 41 40 39 40 39 40 40 40 41 41 39 36 35 39 40 41 40
Tank
Post Rinsing
60 - 80 41 40 38 41 40 40 41 38 43 43 42 38 41 38 40 39 42 39 39 38 36 39 36 40
Tank 1
Post Rinsing
60 - 80 68 60 59 58 58 56 58 55 59 57 58 56 56 58 56 63 74 73 61 58 57 50 55 58
Tank 2
Final Drying
100 - 130 76 145 149 148 148 145 149 152 151 151 152 152 147 152 152 OFF OFF 119 145 149 148 150 152 152
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, October 04, 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 19 22 23 25 25 25 25 26 29 37 37 36 36 38 38 38 40 39 40 39 39 39 40 39

Alkaline Tank 1 50 - 70 62 63 64 65 63 65 63 64 62 65 62 63 64 66 65 66 64 67 65 65 62 65 65 65

Alkaline Tank 2 50 - 70 63 60 63 61 65 63 64 64 63 65 65 62 66 62 65 65 64 65 65 65 65 63 66 66

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

Coagulant Oven 1 100 - 200 120 120 120 120 120 120 120 120 120 120 121 118 118 116 118 116 116 118 114 116 118 116 118 118

Coagulant Oven 2 100 - 200 117 117 119 119 117 119 119 117 119 119 119 118 116 117 115 118 116 117 117 118 116 115 116 118
Former Temp
Before Latex 65 - 75 63 63 63 63 63 63 63 63 63 62 64 64 66 66 65 65 63 66 66 63 60 60 62 64
Tank 1
Latex Tank 1 45 - 55 39 40 38 38 39 41 40 40 40 42 41 41 42 41 41 40 40 41 39 39 40 41 40 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 39 40 41 38 40 41 41 40 40 41 40 39 41 40 41 41 41 41 41 40 41 42 43 42
Tank 2
Latex Tank 2 32 - 36 31 32 32 32 32 32 32 32 32 33 28 33 32 33 32 32 32 32 32 33 33 33 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 46 48 47 46 45 43 48 52 53 57 60 58 55 60 61 58 63 60 61 61 59 59 60 49

Pre-Leaching T2 55 - 65 47 65 67 60 56 52 51 50 47 35 62 65 61 62 53 45 45 50 63 64 66 63 47 48

Pre-Leaching T3 45 - 55 44 48 51 54 55 54 54 54 52 54 56 56 56 54 55 55 56 56 56 52 55 55 53 53

Pre-Leaching T4 45 - 55 44 44 43 45 45 50 49 49 46 47 50 51 51 50 51 50 51 51 50 52 51 52 48 45
Date Thursday, October 04, 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 - 130 120 116 120 120 120 123 121 123 120 120 120 120 116 120 120 120 120 120 120 120 120 125 123 127
(L1 – L10)
Main Oven Z3
100 - 130 116 117 117 115 115 116 117 119 111 115 115 115 115 115 115 115 112 120 120 120 120 121 122 122
(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 - 130 112 112 113 111 112 114 114 114 112 111 112 113 113 113 113 114 114 114 114 114 113 115 116 116
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 118 118 120 118 125 123 123 120 112 120 120 120 116 120 120 120 120 116 120 116 129 121 130
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 65 65 68 65 65 68 64 67 62 64 61 63 64 66 65 67 68 66 64 60 66 68 69 67

Cooling Tank 3 50 - 70 61 60 61 60 61 61 61 61 59 59 59 61 55 57 60 58 60 61 63 61 63 63 63 64

Cooling Tank 4 40 - 60 57 55 54 57 55 58 58 58 55 58 54 58 57 56 56 58 59 59 55 59 59 59 59 58

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

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

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 43 42 43 44 44 42 44 42 44 44 44 40 43 42 43 42 45 42 45 44 43 45 44
Tank 1
Post Rinsing
60 - 80 43 44 43 43 44 43 45 43 43 44 43 43 43 44 41 45 45 44 44 45 45 40 45 46
Tank 2
Final Drying
100 - 130 64 92 94 94 91 92 88 89 88 88 88 89 90 91 92 94 96 97 97 98 97 94 90 92
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, October 04, 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 59 59 61 59 60 60 60 59 58 59 59 59 62 63 59 63 49 50 59 59 59 62 65

Alkaline Tank 1 50 - 70 67 67 66 65 66 65 63 64 64 65 65 65 65 65 67 67 65 63 61 61 64 63 67 69

Alkaline Tank 2 50 - 70 73 73 71 71 71 68 67 69 70 70 69 69 69 57 57 68 67 70 66 68 68 66 69 71

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

Coagulant Oven 1 100 - 200 127 128 126 126 126 128 126 126 128 128 128 126 121 117 123 119 116 118 120 118 123 120 118 116

Coagulant Oven 2 100 - 200 126 127 127 127 127 127 123 127 124 124 124 124 117 119 116 119 116 114 117 117 119 119 117 115
Former Temp
Before Latex 65 - 75 61 64 65 65 65 65 60 64 64 64 62 65 64 65 64 64 63 63 62 63 63 60 63 64
Tank 1
Latex Tank 1 45 - 55 40 41 42 41 41 42 43 43 42 39 42 41 42 42 42 41 41 41 42 41 40 40 41 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 40 40 40 40 39 40 43 42 40 40 41 42 40 40 41 42 42 41 42 41 40 42 42 44
Tank 2
Latex Tank 2 32 - 36 30 30 31 31 30 30 30 29 30 31 31 30 30 30 30 30 30 30 30 30 30 30 30 29

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 41 45 45 46 45 47 47 47 48 49 52 54 42 46 49 49 48 50 47 45 48 46 49

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

Pre-Leaching T3 45 - 55 49 49 48 48 49 48 49 48 47 45 47 50 49 49 49 49 49 49 48 48 48 48 49 49

Pre-Leaching T4 45 - 55 53 54 52 54 53 53 53 52 53 53 52 52 52 51 53 52 52 52 51 52 53 52 53 52
Date Thursday, October 04, 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 - 130 117 116 114 117 116 115 115 116 114 115 116 116 116 117 117 117 118 118 118 118 113 117 117 118
(L1 – L10)
Main Oven Z3
100 - 130 123 123 123 123 123 123 121 121 121 121 122 122 123 120 123 123 124 124 124 124 124 124 124 125
(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 - 130 125 125 125 125 125 125 127 127 125 125 124 125 125 125 125 125 121 125 125 125 125 129 129 130
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 122 122 123 123 122 123 124 124 121 121 122 119 122 123 123 123 123 119 124 120 123 124 124 126
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 48 49 49 47 48 48 48 48 47 47 49 49 47 50 50 48 50 50 48 49 49 47 49 49

Chlorine Tank 2 40 - 60 46 46 47 48 48 48 48 46 47 47 47 46 46 48 41 45 44 46 46 44 47 48 48 48

Soak Rinsing
40 - 70 55 55 55 55 54 53 54 53 53 53 54 55 52 56 55 56 56 56 56 54 55 53 53 55
Tank
Post Rinsing
60 - 80 44 44 45 45 44 45 45 45 43 43 45 44 45 45 44 43 44 44 44 44 45 43 45 45
Tank 1
Post Rinsing
60 - 80 42 43 43 44 43 44 43 44 43 42 43 43 44 44 42 43 43 42 43 42 43 44 44 44
Tank 2
Final Drying
100 - 130 70 68 65 68 67 59 70 70 70 64 65 63 62 59 62 64 71 71 71 OFF OFF OFF 72 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) 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, October 04, 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 62 62 62 63 63 61 61 61 61 57 42 56 62 61 63 64 64 65 64 63 62 61 63 63

Alkaline Tank 1 45 - 75 66 66 64 65 66 64 64 64 65 64 61 41 56 65 66 65 67 67 66 65 65 64 65 68

Alkaline Tank 2 45 - 75 69 69 69 69 67 68 66 67 68 68 65 63 38 56 66 67 69 70 68 68 68 66 69 70

Coagulant Tank 45 - 60 53 52 54 53 54 54 52 53 52 53 53 52 52 52 52 53 53 52 53 53 53 53 53 54

Coagulant Oven 1 100 - 200 131 131 131 129 131 131 131 128 131 130 128 128 128 128 128 130 131 131 131 134 133 130 128 126

Coagulant Oven 2 100 - 200 132 128 130 132 132 132 132 130 132 132 128 133 130 132 132 132 132 132 132 136 132 132 130 128
Former Temp
Before Latex 60 - 75 63 64 64 62 62 62 62 63 62 63 61 63 63 64 63 65 65 66 63 65 64 64 64 62
Tank 1
Latex Tank 1 40 - 55 43 43 44 44 44 43 44 44 43 45 45 45 45 44 43 44 44 45 44 44 45 44 45 44

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 39 40 40 41 41 41 41 40 40 40 40 42 40 40 40 42 41 41 41 42 40 42 40 42
Tank 2
Latex Tank 2 30 - 36 33 32 33 32 32 32 33 33 33 33 33 34 34 33 33 33 32 32 33 33 32 32 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 45 43 43 42 42 41 40 38 36 32 34 36 40 44 46 44 44 44 43 46 43 42 43 47

Pre-Leaching T2 50 - 65 63 61 61 61 62 62 59 60 61 58 56 59 61 60 61 61 61 61 60 62 60 60 62 64

Pre-Leaching T3 45 - 65 45 44 45 46 44 45 45 44 42 41 41 43 43 43 42 43 42 42 43 42 42 41 45 49

Pre-Leaching T4 40 - 65 54 54 51 53 53 53 52 52 52 51 49 50 51 52 51 52 53 52 53 51 51 52 52 52
Date Thursday, October 04, 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 - 130 131 133 130 133 118 131 135 131 130 130 130 130 126 126 130 130 126 130 130 122 130 130 140 133
(L1 – L10)
Main Oven Z3
100 - 130 123 121 124 122 120 120 122 125 123 122 122 123 119 124 124 124 120 119 124 127 121 120 123 126
(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 - 130 129 130 131 126 129 127 132 127 130 130 128 127 127 122 123 128 130 130 130 131 128 128 132 130
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 134 134 134 129 129 130 133 132 129 133 133 134 130 134 134 134 134 134 134 133 130 130 134 132
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 66 65 66 65 64 64 65 65 63 65 65 63 65 66 64 67 67 67 67 62 66 68 68

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 43 43 42 43 44 44 43 44 49 42 40 37 37 37 37 38 38 38 38 38 39 39 38 38

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 57 57 56 55 54 56 54 54 55 54 57 58 58 56 59 59 58 56 58 57 56 56 56 52
Tank 1
Post Rinsing
40 - 80 44 45 45 46 44 45 45 44 45 47 44 44 44 44 44 44 44 44 43 44 45 43 43 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) 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, October 04, 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 58 54 57 57 55 56 57 57 55 58 58 56 58 58 59 60 59 56 56 56 58 57 55

Alkaline Tank 1 45 - 75 69 68 68 67 68 68 67 68 66 66 66 64 68 65 69 69 70 68 69 66 64 67 68 69

Alkaline Tank 2 45 - 75 59 59 58 57 59 56 57 53 55 56 56 57 56 58 58 56 56 58 53 53 57 55 53 57

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

Coagulant Oven 1 100 - 200 139 137 139 139 139 139 137 139 139 137 139 139 139 138 138 137 137 137 137 135 137 137 137 137

Coagulant Oven 2 100 - 200 138 138 135 131 135 138 135 135 135 135 138 137 136 136 136 133 136 136 136 136 136 136 131 136
Former Temp
Before Latex 65 - 75 71 62 68 67 68 68 69 66 64 70 69 68 66 71 70 72 67 66 68 70 68 67 69 71
Tank 1
Latex Tank 1 40 - 55 39 38 38 38 39 41 41 40 40 40 38 40 41 40 41 39 41 43 41 42 42 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 40 38 38 38 38 38 38 38 38 37 40 39 40 39 40 39 40 38 40 38 38 41 40
Tank 2
Latex Tank 2 30 - 36 32 30 31 30 31 31 31 30 31 30 32 30 31 30 32 30 31 31 30 32 32 32 31 32

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

Pre-Leaching T1 55 - 65 41 42 40 42 42 42 41 41 41 38 39 42 42 44 44 44 43 43 43 42 43 41 44 43

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

Pre-Leaching T3 45 - 65 39 40 39 38 37 40 38 38 36 38 38 36 37 38 36 38 34 37 38 36 35 39 38 39

Pre-Leaching T4 45 - 65 39 39 41 40 41 39 36 38 38 37 38 40 40 40 39 41 41 40 40 39 40 38 40 45
Date Thursday, October 04, 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 - 130 120 120 120 120 118 120 118 118 116 120 120 120 120 116 120 120 120 120 120 116 120 120 120 120
(L1 – L10)
Main Oven Z3
100 - 130 117 117 119 117 119 119 117 117 119 119 119 119 119 119 119 119 119 115 119 119 119 119 119 111
(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 - 130 123 123 121 123 121 122 120 120 122 122 121 121 119 122 122 122 123 122 123 117 122 122 122 122
(L1 - L10)
Main Oven Z6
(L1 – L10 except 100 - 130 120 120 120 120 120 118 120 118 120 119 116 120 120 120 120 120 120 120 120 120 116 120 120 120
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 61 64 61 64 63 59 59 54 61 63 61 63 63 62 64 62 64 62 60 64 64 62 64

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

Cooling Tank 4 40 - 60 53 51 51 51 50 52 52 50 54 49 50 49 51 49 53 56 56 52 54 50 52 54 54 50

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

Chlorine Tank 2 40 - 60 47 49 50 50 48 50 49 48 49 51 48 52 51 49 49 54 54 50 53 53 49 52 48 51

Soak Rinsing
40 - 70 74 76 78 77 78 80 76 76 74 79 74 74 74 79 76 77 77 77 80 80 75 77 77 75
Tank
Post Rinsing
40 - 80 43 41 45 43 44 45 45 46 45 45 45 44 43 41 44 43 44 44 47 45 44 44 44 40
Tank 1
Post Rinsing
40 - 80 38 43 42 43 44 41 44 41 40 40 42 42 43 42 42 41 40 43 40 44 38 41 44 40
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, October 04, 2018

Line Production
1 0
2 137222
3 314720
4 533371
5 0
6 34454
7 3534
8 0
9 0
10 0

TOTAL ALL: 1023301

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