Environment Monitoring Ispe Done.ppt
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QUALITY FORUM Jumat, 15 February 2019
3/30/2019
PEMBACAAN DOA
3/30/2019 2019/3/30
Kalbe Panca Sradha Trust is the glue of life Saling percaya adalah perekat diantara kami Mindfulness is the foundation of our action Kesadaran penuh adalah dasar setiap tindakan kami Innovation is the key to our success Inovasi adalah kunci keberhasilan kami
Strive to be the best Bertekad untuk menjadi yang terbaik Interconnectedness is a universal way of life Saling keterkaitan adalah panduan hidup kami 3/30/2019 2019/3/30
COMPANY POLICY: Manajemen dan karyawan PT Finusolprima Farma Internasional (FIMA), mempunyai komitmen melalui:
•Pelayanan yang memuaskan pelanggan •Regulasi yang terkait dengan CPOB, Keselamatan dan Kesehatan Kerja, dan Aspek Lingkungan terpenuhi
•Ikut menciptakan lingkungan kerja yang aman dan sehat, serta mengurangi dan mencegah resiko kecelakaan kerja dan melindungi lingkungan
•Mutu produk yang dihasilkan sesuai dengan CPOB dan persyaratan pelanggan; melalui penerapan ilmu pengetahuan, teknologi ramah lingkungan dan aman bagi pekerja
•Aktif melakukan perbaikan berkesinambungan di semua aspek
3/30/2019 2019/3/30
3/30/2019 2019/3/30
Theme : Environmental Monitoring in Sterile Production Date : 15 Feb 2019 Location : Audi 1 Lantai 3 Gedung Produksi
3/30/2019 2019/3/30
Environmental Monitoring ISPE Training 19 September 2019
15 February 2019 Abdelhaq Setya Subarkah Yohanna Margaretha Haloho
Outline
1.Reason for Environment Monitoring Program 2.Environment Monitoring Program 3.Report and Trend Analysis
1.Reason for Environment Monitoring Program
2. Environmental Monitoring Program
Sampling Point for Particle Monitoring (ISO 14644-1 )
Monitoring Gowning (Add.) 1. Sterile Drug Products Produced by Aseptic Processing (FDA, 2004)
How to perform contact plate testing (Additional)
3/30/2019
36
Storage, Use and Shipping of Surface Contact
• Storage – Contact plate storage (2-25 oC) – Do not freeze and minimize exposure to light – Plates should be stored with agar up and the lid down to minimize the potential of contamination from condensation – Always wear gloves when performing sampling – Do not use expired plates
3/30/2019
37
Preparation – Prepare a test diagram for the areas that are to be tested and label plates with the corresponding location identification. – Ensure that the label cannot be readily wiped off or removed. RODAC plates are prepared so that the agar surface is convex for sampling flat surfaces. – Prior to sampling, the plates should be warmed to room temperature in the plastic sleeve for approximately 15-20 minutes with agar up and the lid down. Remove the quantity of plates from the sleeve that are required for testing. – The location/site identification should be written on the base (agar portion, not the lid) of the plate.
3/30/2019
38
SAMPLING – While wearing gloves, remove the lid from the plate with one hand. – With the other hand, hold the base (agar portion of the plate) with thumb and middle finger. – Use the index finger to gently press the plate on the test surface. Make sure the entire agar surface touches the test surface. – Do not move the plate laterally while sampling as it will spread contaminants making enumeration difficult. Place the lid back on the plate and tape closed. – Be sure to clean the test area after sampling to remove any residual growth media remaining on the surface.
3/30/2019
39
3 COMMON MISTAKES IN CP https://www.youtube.com/watch?v=4ZA_0rPmA6s USE Air Sampler https://www.youtube.com/watch?v=RM9Dd1LRSxQ&t=20s active vs passive AS https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3444341/pdf/1471-2458-12-594.pdf
Shipping – All RODAC plates should be packaged in a sleeve or bag, and the bag or sleeve should be bubble-wrapped and shipped in a cooler with freezer packs. – Freezer packs should not be packed on top of or in direct contact with the plates. – Ideally, samples should be received by Laboratories the same day as sampling.
Incubation – Incubation is 3-5 days at 30-35ºC. If additional incubation is requested, the standard is 2-4 days at 2025ºC after the initial 3-5 days @30-35ºC.
3. Report and Trend Analysis
Post Test 1.Parameter should be monitored in Environmental Monitoring Program, except… A.Particle B.Humidity C.Temperature D.Viable E.Overtime
Post Test 2. These are methods of viable monitoring, except… A.Contact Plate B.Swab C.Finger dab D.Active Particle Sampler E.Active Air Sampler
Post Test 3. Location of viable testing in Environment Program must be determined based on… A. Trend Analysis B. Location which result always within the specification C. Compendial D. Risk Based Decision E. No requirement
Post Test 4. If out of specification EM occur, is batch related shall be rejected? ……………………………
Post Test 5. Mention and explain, what should be investigated if out of specification EM occurred! ……………………………
3/30/2019
PEMBACAAN DOA
3/30/2019 2019/3/30
Kalbe Panca Sradha Trust is the glue of life Saling percaya adalah perekat diantara kami Mindfulness is the foundation of our action Kesadaran penuh adalah dasar setiap tindakan kami Innovation is the key to our success Inovasi adalah kunci keberhasilan kami
Strive to be the best Bertekad untuk menjadi yang terbaik Interconnectedness is a universal way of life Saling keterkaitan adalah panduan hidup kami 3/30/2019 2019/3/30
COMPANY POLICY: Manajemen dan karyawan PT Finusolprima Farma Internasional (FIMA), mempunyai komitmen melalui:
•Pelayanan yang memuaskan pelanggan •Regulasi yang terkait dengan CPOB, Keselamatan dan Kesehatan Kerja, dan Aspek Lingkungan terpenuhi
•Ikut menciptakan lingkungan kerja yang aman dan sehat, serta mengurangi dan mencegah resiko kecelakaan kerja dan melindungi lingkungan
•Mutu produk yang dihasilkan sesuai dengan CPOB dan persyaratan pelanggan; melalui penerapan ilmu pengetahuan, teknologi ramah lingkungan dan aman bagi pekerja
•Aktif melakukan perbaikan berkesinambungan di semua aspek
3/30/2019 2019/3/30
3/30/2019 2019/3/30
Theme : Environmental Monitoring in Sterile Production Date : 15 Feb 2019 Location : Audi 1 Lantai 3 Gedung Produksi
3/30/2019 2019/3/30
Environmental Monitoring ISPE Training 19 September 2019
15 February 2019 Abdelhaq Setya Subarkah Yohanna Margaretha Haloho
Outline
1.Reason for Environment Monitoring Program 2.Environment Monitoring Program 3.Report and Trend Analysis
1.Reason for Environment Monitoring Program
2. Environmental Monitoring Program
Sampling Point for Particle Monitoring (ISO 14644-1 )
Monitoring Gowning (Add.) 1. Sterile Drug Products Produced by Aseptic Processing (FDA, 2004)
How to perform contact plate testing (Additional)
3/30/2019
36
Storage, Use and Shipping of Surface Contact
• Storage – Contact plate storage (2-25 oC) – Do not freeze and minimize exposure to light – Plates should be stored with agar up and the lid down to minimize the potential of contamination from condensation – Always wear gloves when performing sampling – Do not use expired plates
3/30/2019
37
Preparation – Prepare a test diagram for the areas that are to be tested and label plates with the corresponding location identification. – Ensure that the label cannot be readily wiped off or removed. RODAC plates are prepared so that the agar surface is convex for sampling flat surfaces. – Prior to sampling, the plates should be warmed to room temperature in the plastic sleeve for approximately 15-20 minutes with agar up and the lid down. Remove the quantity of plates from the sleeve that are required for testing. – The location/site identification should be written on the base (agar portion, not the lid) of the plate.
3/30/2019
38
SAMPLING – While wearing gloves, remove the lid from the plate with one hand. – With the other hand, hold the base (agar portion of the plate) with thumb and middle finger. – Use the index finger to gently press the plate on the test surface. Make sure the entire agar surface touches the test surface. – Do not move the plate laterally while sampling as it will spread contaminants making enumeration difficult. Place the lid back on the plate and tape closed. – Be sure to clean the test area after sampling to remove any residual growth media remaining on the surface.
3/30/2019
39
3 COMMON MISTAKES IN CP https://www.youtube.com/watch?v=4ZA_0rPmA6s USE Air Sampler https://www.youtube.com/watch?v=RM9Dd1LRSxQ&t=20s active vs passive AS https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3444341/pdf/1471-2458-12-594.pdf
Shipping – All RODAC plates should be packaged in a sleeve or bag, and the bag or sleeve should be bubble-wrapped and shipped in a cooler with freezer packs. – Freezer packs should not be packed on top of or in direct contact with the plates. – Ideally, samples should be received by Laboratories the same day as sampling.
Incubation – Incubation is 3-5 days at 30-35ºC. If additional incubation is requested, the standard is 2-4 days at 2025ºC after the initial 3-5 days @30-35ºC.
3. Report and Trend Analysis
Post Test 1.Parameter should be monitored in Environmental Monitoring Program, except… A.Particle B.Humidity C.Temperature D.Viable E.Overtime
Post Test 2. These are methods of viable monitoring, except… A.Contact Plate B.Swab C.Finger dab D.Active Particle Sampler E.Active Air Sampler
Post Test 3. Location of viable testing in Environment Program must be determined based on… A. Trend Analysis B. Location which result always within the specification C. Compendial D. Risk Based Decision E. No requirement
Post Test 4. If out of specification EM occur, is batch related shall be rejected? ……………………………
Post Test 5. Mention and explain, what should be investigated if out of specification EM occurred! ……………………………
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