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Production Facilities
Since the manufacturing plant was formerly operated and owned by multinational company, it complies with Good Manufacturing Practice(GMP) set by the Indonesian Ministry of Health and its still being operated by highly experienced group of pharmacists. The plant covers an area of 2 hectare and equipped with all the standard GMP requirement for production machineries and controlled by strict method of quality control.
Novell has finished its factory expansion in July 2003. The new factory is built based on Australian TGA's standard and is closely supervised by an Australian engineering company.
The new factory is capable of producing sterile products (liquid and powder) as well as other standard oral dosing such as tablets and capsules.
The details of infrastructure are as follows :
| Product Development Room |
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In order to ensure good quality products, product development room is designed and conditioned to have a similar process, equipment and method as compared to those in production process. |
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| Air Handling Unit |
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One of the important aspects of pharmaceutical production is supply and management of air. Novell chooses CARRIER for its air handling unit which is equipped with high static pressure design, flow measuring sensor to ensure constant pressure/air flown and also automatic volume damper. Indicator filter block is also implemented to maintain the AHU system. |
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The specifications for each room/zone are as follows :
| Zone |
Category |
Air change Per hour |
Medium Filter |
HEPA Filter |
| A |
White |
> 120 times |
80 - 85 % |
99.99 % |
| B |
White |
> 50 times |
80 - 85 % |
99.99 % |
| C |
Semi White |
> 30 times |
80 - 85 % |
99.99 % |
| D |
Grey |
> 15 times |
90 - 95 % |
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| Room Condition |
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All production room (floor, ceiling, wall) is designed based on international GMP: circular shape at corners, no dead angle, multilayered/self leveling epoxy coating for all surface, air lock room. Materials for all doors and windows are aluminum anodized. Pressure differential between different room's zone. Entrance route from lower class to higher class equipped with air lock room and for personal entrance to white area (grade B) all personnel pass through air shower. |
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For solid preparation: tablet, capsule, and powder. The machine has been well validated: IQ, OQ & PQ. |
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| Reverse Osmosis-EDI System |
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Novell understands the importance of water management especially for pharmaceutical production. The process of water are as follows: Deep well - sand filter - filter 5u - potable water - carbon filter and softener - water for RO-EDI machine supply. Novell chooses RO-EDI CHRIST (Germany) that has characteristic of: yields permeate/ output (automatic control valve, quality conductivity < 0.5 m, 25 oC, TOC < 50 ppb, material contact: SS316 L, 100% orbital welded, max refinement level 0.6 Ra), microbiological contamination < 10 cfu/ ml.
Water circulation is designed as a close loop system, using zero dead leg system (valve, circulation and piping <3d), with sloping > 0.5%. All the piping materials are Stainless Steel 316 Low Carbon, with Ra < 0.6. Pumps: sanitary & pharmaceutical pump grade (Alva Laval), with velocity > 2 m/s.
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| WATER DISTILLATOR (Water For Injection) |
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Supply from: Purified water COR, Multi effect still, 3 column, conductivity in line Circulation piping: SS 316 L, Close loop system, Alva Laval (ASME BPE), 100% orbital welded, Boroscopic test, > 30% X-Ray test. Velocity > 2 m/s, temp circulation 80 oC
Validation: IQ, OQ, output.
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| Pure Steam Generator |
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The machine is from COR-Italy with specification output: 340 kg/ hr, 3 bar.
Circulation piping: close loop system, SS 316 L piping (Ra < 0.4, Alva Laval ASME BPE), 100% orbital welded. sloping > 0.5% Qualification: IQ, OQ, validation steam output.
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| Sterilization Method |
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Input: Zone C with double door; Output: zone B, with automatic interlock door (Isolator Technology) PLC system (equipped with 3 flexible temperature probe for sensing temperature at loads) process well validated. Novell chooses the two internationally well known producer of oven and autoclave: LYTZEN and GETINGE.
- OVEN: LYTZEN; type class 100 on chamber, with capacity: 1,000 L for sterilization and depyrogenation; control system: Lytcon 2.
- AUTOCLAVE: GETINGE with capacity: 1,000 L for steam sterilizer, control system: PACS 2000.
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| Washing Ampoule And Vial |
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The machine is Bausch and Stroebel (Germany). Water for injection is used for final rinsing and equipped with 0.22 m filter for drying. Validation of IQ, OQ and washing process.
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| Filling Ampoule & Vial |
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One of the crucial processes in sterile production is filling the liquid into vial/ampoule. To ensure quality products, Bausch & Stroebel filling ampoule/vial is the preferred machine. The process is exeuted in a qualified room grade B and under Laminar Air Flow. it uses 0.45 filter on gas for ampoule burning - closing ampoule head.
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| Production Output |
The following is Novell's capability in several preparations :
| Tablet compression machine |
Single layer: 100.000 tab/hour
Double layer: 40.000 tab/hour |
| Automatic filling capsule |
6 station @4 filler, 38.000 caps/hour |
| Automatic blistering |
2.100 blister/hour |
| Automatic stripping |
840 strip/hour |
| Automatic ampoule and vial washer |
6.000 ampoule-vial/hour |
| Autoclave |
1.000 L |
| Class 100 dry heat sterilizer |
1.00 L |
| Aseptic Double jacketed mixing tank |
100 L |
| Automatic ampoule filling machine |
3.000 ampoule/hour |
| Automatic vial filling machine |
3.600 vial/hour |
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