Research and Development at Terumo Penpol

The concept of setting up a facility for the manufacture of blood bags was born with Sri.C.Balagopal, an IAS officer of North Eastern Region of India procuring a license from M/S NRDC of India for a basic process developed by M/S. SCTIMST,Kerala in 1984. After considerable deliberations he decided to assess the SCTIMST process on a small scale production before venturing for scale up to a full scale manufacturing facility.

The trial production went off without any hitch even though there were indications of various gaps in knowledge and problem areas.  In due course however, we could make 30 blood bags per day. By the year 1987, a full scale plant was set up at Puliyarakonam with the capacity of 2 million blood bags per year which was built around a film studio  . The operation of the plant was started in March 1987.

Right from the start, we had to face an array of problems  -  defective quality of materials, problems of dust and particulate matter in the anticoagulant, leaks,  poor label quality, unsatisfactory quality of needles and so on. The problems were somehow kept in check but we were soon overwhelmed by a new hitherto unknown problem- fungal growth on blood bag labels which defied all efforts to tame them. In the meantime,   financial contingencies and mounting pressures from the newly established marketing set up forced us to send out thousands of blood bags all over the country. Almost every one of the blood bags created with such loving care, developed dirty looking greenish coatings on the labels.

Our founder Managing Director, Mr  C.Balagopal  took an almost suicidal  but very wise decision to  withdraw every infected bag from the market .This decision caused a terrific monetary loss to the fledgling company. He took another bold decision that in the absence of technical help from others we should solve our problems by our own efforts. With such trust reposed on them, the R& D of the Company rallied with full enthusiasm since finding solutions had become a question of survival for the company. The R&D efforts soon started bearing fruits. The nature of fungal growth was clearly identified and completely eliminated by improved processing steps and the development of an entirely novel process of Steam sterilization. TERUMO PENPOL  strengthened it’s understanding of blood bag technology-new formulations, the role of plasticizers such as TEHTM, BTHC  and others , better packaging materials such as multilayered polymers ,selective reuse of materials and so on. In all over 120 technical reports, 30 research publications and 20 patents stand testimony to our R & D efforts. The R & D work done and the technical reports and patents form the core strength for our Technical excellence among Blood bag manufacturers. Other blood bag manufacturers in India have benefitted quite a lot since they have been using the processes developed by us. M/S PENPOL won the National Award in 1999 from the Government of India for successful development of Indigenous Technology.

M/S Peninsula Polymers Ltd has changed a lot since then. The company merged with M/S Terumo Corporation in the year 1999 - a change that resulted in the input of newer technologies, automation and increase in the production capacity to 25 million blood bags of which around 60% were exported.

In April 2012 M/S Terumo Corporation acquired The Caridian BCT Corporation to enhance their field of operations in global blood transfusion business. Under the new dispensation, M/S Terumo BCT was given over all control of Terumo’ blood bag operations.  Many novel achievements have been made in recent years - such as the development of blood bag systems for the storage of red cells, platelets, plasma, and pediatric bags using non DEHP plasticizers. Other notable areas are the standardization of filters for the removal of leucocytes and pathogens and better quality packaging for blood bags.  Newer areas under consideration are the development of tubes, disposables, and bags for the collection and storage of blood fractions for the versatile field of Apheresis technologies  using non DEHP formulations.   Further expansion of the capacity of Terumo Penpol  to 35 million blood bags per annum is at an advanced stage.

The fascinating story of Terumo Penpol is a saga of how an indigenously grown high technology relating to blood bags survived innumerable technical problems which almost destroyed the company, and developed into one of the most sophisticated blood bag factories in the world by their own R&D efforts.

  • Developing formulations for medical grade sheets, tubes and injection moulding.
  • Developing formulations for making blood bags for the preservation of whole blood, RBC, platelets and blood plasma.
  • Compound preparation with support from external agencies whose capabilities have been developed and standardized by us.
  • Making sheets, tubes, and prototype bags using facilities available at TPL.
  • Testing (physical, chemical and biological) and validation of blood bags as per international standards.
  • Performance evaluation of blood bags for
    • Storage of whole blood.
    • Platelets
    • Red blood cells.
  • Testing and standardization.
    • Whole blood/RBC RBC count, pO2, pCO2, pH, lactate, glucose, plasma Na+, K+, % lysis, HCO3, HGB, HCT, MCV, MCH, MCHC.
    • Platelet Platelet count, pO2, pCO2, pH, lactate, glucose, plasma Na+, K+, MPV, PDW, PLCR.
    • Other tests: -
    • Specialized tests such as RBC morphology, platelet aggregation, residual leucocyte count using flow cytometry, plasma storage studies, toxicity tests etc done in collaboration with approved laboratories.
  • Development and standardization of improved protective outer packaging for blood bags with the objective of improving the efficiency and cost of production.
  • Validation of leucocyte reduction filters.

During the past 7 years we have been actively working for the replacement of DEHP in blood bags.

  • Development of platelet storage bags using DINCH plasticizer.
  • Development of bags for the storage of platelets collected from 6-10 units of blood using high molecular weight PVC plasticized with DINCH.
  • Development of blood bags for the storage of RBC using plasticisers such as DINCH and DOTP.
  • Development of blood bags made using DINCH plasticized PVC for the storage of blood plasma.
  • Development of bags for the storage of whole blood and for peadiatric purposes using PVC plasticized with DINCH.
  • Blood bags made with the non DEHP plasticisers DINCH and DOTP with ACD solution for use with apheresis procedures.
  • Improved blood bags for the storage of RBC with reduced haemolysis using DINCH/DOTP PVC bags.
  • DINCH/DOTP plasticized tubes for apheresis.
  • Blood gas analyser ABL-800
  • Sysmex cell counter XP-100
  • Shimadzu UV spectrophotometer 1700
  • Cryofuge 5500i (Heraeus )
  • Blood storage cabinet (TPL)
  • Platelet agitator (TPL)
  • TACE equipment for blood components separation (Terumo)
  • Waters HPLC

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