Why do prefilled syringes become the preferred choice for biologics?

The history of prefilled syringes

 

The idea of injecting drugs originated from observations of snake bites and William Harvey’s understanding of the circulatory system recorded in the early 1600s. In the first 100 years, scientists such as Christopher Wren conducted experiments with crude instruments, impure drugs, and non-sterile solutions to administer painkillers to dogs and humans. While some people and animals may have survived this experience, it is certain that many did not due to a lack of understanding of microorganisms. However, the relief of severe pain and the knowledge of vaccine administration created the need and motivation for a better understanding of this technology. The Second World War gave rise to the need for convenient packaging of drugs for transport to the battlefield and rapid administration of pain-relieving medications. Before the 1980s, prefilled syringes were seen as relatively niche products. Sanofi and Rhone Poulenc-Rorer introduced pre-filled syringes for heparin and made this delivery method highly successful.

 

Prefilled syringes, also known as pre-filled injectors or pre-filled needles, are a new type of pharmaceutical packaging material that has developed in recent years. They are not medical devices but are part of the drug packaging system, serving the purpose of storing drugs and facilitating regular injections. The first prefilled syringe was developed by the American company BD in 1984 and gradually gained familiarity and acceptance in the US and European markets. Prefilled syringes are primarily used for packaging high-value products such as vaccines, biologics, biochemical products, anticoagulants, and beauty products. They can also be used for surgical irrigation in ophthalmology, otolaryngology, orthopedics, gynecology, etc. China’s research on prefilled syringes started relatively late, with the first glass prefilled syringe being developed by Shandong Weigao Group in 2005. In 2019, the global market for prefilled syringes reached $4.6 billion, making it the fastest-growing form of packaging containers. Currently, prefilled syringes are widely used by vaccine manufacturers such as Wuhan Institute of Biological Products (a subsidiary of China National Pharmaceutical Group), Beijing Institute of Biological Products, and Beijing Kexing Bioproducts. Prefilled syringes have broad application prospects in vaccine formulation.

 

 

Application areas and advantages of prefilled syringes

 

Prefilled syringes refer to syringes that are filled with medication, making it convenient for healthcare professionals and patients to administer drugs. The representative products of prefilled syringes are insulin prefilled syringes. With the rapid development of modern biopharmaceutical technology, self-administered treatment for chronic diseases has become widely used. Prefilled syringes are now commonly used in the fields of anticoagulants, vaccines, hematopoietic stimulants, interferons, and rheumatoid arthritis drugs. Prefilled syringes have the following advantages:

 

  1. More accurate dosing

Prefilled syringes minimize medication residue, ensuring more accurate dosing.

 

  1. Direct injection

Avoids healthcare professionals harming themselves during the drug preparation process or inaccuracies in medication dosing, reducing the chances of medication errors.

 

  1. Convenient and contamination-free use

With prefilled medication, only the needle cap needs to be removed before direct injection, preventing cross-contamination. The drug is not exposed to air, ensuring safe injection.

 

  1. Self-administration capability

Patients with chronic diseases can self-administer medication at home.

 

  1. Convenient transportation and storage

Prefilled syringes are easy to handle, store, and transport, effectively reducing costs.

 

Classification and components of prefilled syringes

 

Prefilled syringes mainly come in two types: glass prefilled syringes and polymer prefilled syringes. The products are divided into two categories: with injection needles and without injection needles. The specifications for glass products range from 0.5 mL to 20 mL, and for plastic products, from 5 mL to 50 mL. Prefilled syringes are generally composed of a barrel, plunger, push rod, cone, and cap, as shown in Figure 1. Syringes with injection needles have the needle embedded, consisting of a needle barrel, needle cap, plunger, and push rod. Syringes without needles have two types: cone-shaped and screw-type. The cone-shaped syringe consists of a needle barrel, cone-shaped head cap, plunger, and push rod, while the screw-type syringe consists of a needle barrel, screw-type head cap, screw-type head, plunger, and push rod.

 

Figure 1

The injection needles of prefilled syringes are generally made of stainless steel, while other parts are made of high-quality glass, plastic, and rubber, ensuring the safety and reliability of the product. Furthermore, prefilled syringes eliminate the transfer of drugs from packaging to syringes, effectively reducing waste caused by adsorption and avoiding cross-contamination and secondary pollution. Moreover, prefilled syringes use a quantitative filling method, which is more accurate than manual syringe filling by healthcare professionals.

 

Technical standards for prefilled syringes

 

Various components of prefilled syringes have separate standards, such as borosilicate glass syringe barrels for prefilled syringes (YBB00062012), stainless steel injection needles for prefilled syringes (YBB10072012), butyl rubber pistons for prefilled syringes (YBB30012012), bromobutyl rubber pistons for prefilled syringes (YBB30022012), and polyisoprene rubber needle cap for prefilled syringes (YBB30032012). The domestic standard is YBB00112004-2015, which includes the following main technical indicators:

 

  1. Barrel sealing performance: The barrel sealing performance directly affects its usability and is a key indicator of concern for manufacturing companies.
  1. Stress value of prefilled syringes: During the manufacturing process of glass prefilled syringes, annealing is required. If the internal stress of the prefilled syringe exceeds the standard, there is a possibility of spontaneous rupture or breakage induced by slight external forces, posing significant safety hazards. Scientific testing of the internal stress of prefilled syringes can help companies analyze and improve the internal stress indicators of the product, effectively reducing market risks.
  1. Plunger sliding performance: Plunger sliding performance is an important test indicator for prefilled syringes because when pushing the plunger, there is a certain resistance between the plunger and the inner wall of the glass barrel. Excessive force can cause injection difficulties, while insufficient force can lead to rapid and dangerous injection.
  1. Steelness testing for injection needles: Stainless steel needles require a certain degree of rigidity to ensure that the needles are not easily bent during application, reducing the possibility of medical accidents.

Major manufacturers of prefilled syringes

 

There are numerous manufacturers of prefilled syringe components in the biopharmaceutical, monoclonal antibody, and blood product fields. The prefilled product market has huge development potential, with a market size of approximately 350 million syringes in China. According to the registration information published by the former Center for Drug Evaluation of the National Medical Products Administration (NMPA/CDE), the major importers of prefilled syringe components include BD, Gerresheimer Buende GmbH, SCHOTT Schweiz AG, Nipro Pharma Packaging International, Ito Corporation, Terumo Corporation, and Daicel Chemical Industries, Ltd.

 

LTPM CHINA is a professional pharmaceutical machinery and service provider dedicated to providing efficient and high-quality outsourcing solutions for global partners in the biopharmaceutical industry. LTPM CHINA not only flexibly meets the increasing demands of partners for different processes and types of formulation production lines but also fully integrates the production of bulk drugs and finished products, accelerating the delivery of partner projects to the market, reducing technology transfer time, and lowering risks. This integrated service provides the continuity required for production and enables partners to reach milestones faster to meet the dynamic needs of their projects.

 

LTPM CHINA’s filling production line has adjustable filling speed, and during continuous production, the filling volume is controlled by online weighing. They have fully automatic filling and capping production lines (A-grade environment within B-grade background) with the option of operating restricted entry barrier systems (oRABS), as well as fully automatic bottle washing and depyrogenation equipment.

 

Conclusion

Prefilled syringes reduce dosing errors during medication preparation by healthcare professionals, avoid uneven concentration during drug withdrawal, improve patient compliance, and ensure sterility. In terms of transportation and storage, prefilled syringes are easy to handle, store, and transport, effectively reducing costs. Due to their significant advantages, prefilled syringes are highly favored in the field of biopharmaceuticals, and the market demand is continuously increasing.

Your Best Solution Here!

Reach out to our experts.