Facility
Syncom’s state of the art manufacturing facility is centrally located at Pithampur which is in central part of India and is in vicinity of dry port, facilitating exports. Syncom’s plant is WHO-GMP and ISO 9001:2008 certified and all our production activities follow GOOD MANUFACTURING PRACTISE in accordance with cGMP norms. Quality system compliance in the campus is under regular assessment by quality audits comprising of senior personal from QC, QA, Production AND Engineering from industry. Our team is all set to satisfy global customer requirement meeting quality expectation and specification for a wide range of product portfolio.
Injections:
The facility is comprised of fully automated washing to packing Injectable lines (4 Lines/3 Tunnels), each having separate AHU systems. We have Ampoule Washing Machine (with ultrasonic system), Rotary Vial Washing Machine: ARVW - 120, Auto clave (HPHV system), Four head Ampoule filling & sealing machine, Automatic liquid vial filling machine with rubber bunging with aluminum cap sealing arrangement, machine for visual checking, Ampoule labelling machine & vial labelling machine.
For Dry powder injections we have vial washing machine with siliconisation tank, rubber bung machine with siliconisation tank, dry heat sterilizer, autoclaves, Powder vial filling, rubber stoppering, cap sealing machine ( AHPE - 120), Vial labelling machine.
Tunnel System: It is a highly advanced technology used for the sterilization of the product by means of dry heat. It is a compacted system for dry heat sterilization. It is provided with four zones in case of vials namely drying zone, sterilizing zone, cooling zone & stabilizing zone, while in case of ampoule there is no stabilizing zone. One end of the tunnel is attached with washing area while the other end is attached with sterile filling area by means of a diaphragm. Desired temperature for sterilization is achieved in sterilizing zone for specified time period to ensure complete sterilization of vials and ampoules.
In all departments’ man & material flow is in uni-direction starting from materials receipt to finished product distribution/dispatch.
Tablets & Capsule
The tablet/capsule section is having huge capacity with 5 fabrication areas which are epoxy coated and 12 compressions / filling cubical. Each one is classified, pressure differential there in and working at 22 +/- 2 degrees.
The equipments installed are high speed sophisticated one like GIGA and MEGA press tablets compression (75 to 35 stations double rotary, PC monitored). The cubical is designed with separate AHU/Dust extraction/pressure differential system to meet the environment control norms.
Capsule department has high speed filling machine which consists of capsule hopper magazine, raceway & push plate, rectifier block loading rings & rotary table for powder filling.
In-process test are done during the production operation. When there is product change over, complete thorough cleaning & washing of all equipment coming in contact with the new product is done & the sample of rinse water of the equipment is tested to see the traces of previous products, which should be completely removed as per the SOP. Flow sheets of the various production operations & all the records related to production operation are maintained.
In all departments’ man & material flow is in uni-direction starting from materials receipt to finished product distribution/dispatch.
Ointments:
We have automatic tube filling, sealing & crimping machine from square pharma & also have batch fabrication equipment for 500 kg. Batch size. We have facility for filling and packing in both lami-tubes and aluminum tubes; containers (plastic and metal) and inhalers. The ointment vicinity is a classified area with separate AHU system.
In all departments’ man & material flow is in uni-direction starting from materials receipt to finished product distribution/dispatch.
Dry Syrup
In liquid department we have a single line high speed machine in classified area. Department have separate air handling system which disallows cross contamination of air. The area is furnished with flush type fall ceiling and lighting fixtures, flooring with epoxy jointing. DM water system is through SS316L piping loop, which is internally Electro polishes and externally buffed to meet WHO-GMP standards. In process quality control checks are documented and conducted during regular operations to meet the required quality standard.
In all departments’ man & material flow is in uni-direction starting from materials receipt to finished product distribution/dispatch.
B - Lactum Department:
We have designed a complete separate building for the B-Lactum molecules as per GMP norms for Injectable, Capsules, Tablets & Dry Syrups. B-lactum block has individually separated closed loop air conditioning system. There are independent air handling unit with separate supply and return of air to avoid cross contaminations between Non B-lactum unit. All quality controls system are documented and followed independently for B-lactum molecules.
Packing Variants
| DEPARTMENT | AVAILABILITY | |
|---|---|---|
| Tablets | Alu-Alu / Blister / Strip / Bulk Pack | |
| Capsules | Alu-Alu / Blister / Strip / Bulk Pack | |
| Liquid Orals | 15 ml / 30 ml / 60ml / 100 ml / 200 ml / 225 ml / Glass / Pet Bottle pack | |
| Injections | Vial | 2 ml / 5 ml / 10 ml / 30 ml /50 ml / 100ml |
| Ampoule | 1 ml / 2 ml / 3 ml / 5 ml /10 ml | |
| Dry Powder | 20 mg to 3 gm vial | |
| Dry Powder (orals) | 30 ml / 60 ml Glass / Pet Bottle and Sachet ORS on FFS | |
| Ointments | Lami /Aluminium tube | 5 gm/ 7 gm / 10 gm / 15 gm / 20 gm / 25 gm / 30 gm |
| Plastic Container | 15 gm / 25 gm / 28 gm / 65 gm / 250gm / 500 gm | |
Capacity
| Sr.No. | DEPARTMENT | CAPACITY PER DAY |
|---|---|---|
| 1 | Non B-Lactam Block (SVP) | |
| (a) Liquid Vials (Injections) | 100,000 Vials | |
| (b) Liquid Ampoules (Injections) | 150,000 Ampoules | |
| 2 | TCL-BLOCK | |
| (a) Tablets | 30,000,000 Tablets | |
| (b) Capsules | 15,000,000 Capsules | |
| (c) Liquid Orals | 60,000 Bottles | |
| 3 | Ointment ( Non sterile in Lemi / Aluminium) | 50,000 Tubes |
| 4 | FFS ORS Powder | 100,000 Pouches |
| 5 | B-Lactam Block | |
| (a) Dry Powder Injections | 60,000 Vials | |
| (b) Dry Syrups | 20,000 Bottles | |
| (c) B-Lactam Capsules | 300,000 Capsules | |
| (d) Tablets | 1,000,000 Tablets |
Quality System
The QMS (Quality Management System) is established through document & data control. Regular inter-departmental self inspections, training of employee on GMP, hygiene and precaution against cross contamination and mix up are conducted.
The employee under-go medical examination once a year through registered medical practitioner, to establish there physical fitness/free from contagious diseases. Eye check up is followed for each employee deployed at optical checking work.
There is a well defined sanitization system which is followed in order (as and when applicable).
Qualifications and Revalidations of AHU, measuring devices and calibrations etc. are followed at definite interval of time, establishing uninterrupted quality/consistency of product.
The vendor’s approval system is established for material procurement and its quality consistency.
Water being the key raw material in pharmaceutical formulations is from single municipal source.
Purified water generation, storage, volume and usage are thoroughly regulated by well defined water system, comprising of SS316 loop line/vessel system maintained at 70 +/- 10 degrees.
There is a well defined change control system which is followed in order (as and when applicable).
Quality Control Systems
The laboratory is well equipped comprising of sophisticated instruments viz. HPLC, FTIR, GLC and UV/VIS spectrophotometer etc. besides chemical and micro-biological analysis.
Quality control of each input and finished product is subjected for analysis through written down test specifications/methods as applicable (chemical / instrumental / micro-biological).
Sampling is followed as per established sampling plan which are in accordance with cGMP norms.
Stability of finished products:
The products are subjected for stability at accelerated conditions of temperature and RH. One batch every year for each product is subjected for real time study.
