![]() ![]() This is intended to further reduce the risk of contamination from human contact with processing equipment. Principally, these amendments require pharmaceutical companies to minimise the number of manual interventions across aseptic cleanroom processes as much as possible - such as during maintenance or cleaning of equipment. LPZ areas make use of laminar airflow technology to minimise contamination but do not need to completely eliminate it The Annex 1 changes focus on preventing cross-contamination and other processes that will significantly affect requirements for cleanroom spaces. For instance, amendments to Annex 1 of the GMP are due to come into force in August of 2023, which applies to all drugs that may be sold in the EU, no matter where they are manufactured.Ī failure to address Annex 1 by August could result in production line closure until the standards are met, which is an expensive proposition. In addition to these guidelines, manufacturers must ensure that their aseptic processes align with new regulatory updates in the markets where they operate. In the EU, the cleanrooms are categorised as Grade A, B, C, or D. ![]() In the US, the Food & Drug Administration classifies cleanrooms from ISO8 - the least strict - to ISO5- the most stringent - to remain compliant with ISO14644. All cleanroom environments must adhere to Good Manufacturing Practice (GMP) guidelines for sterile products - meaning that they must be classified according to the required characteristics of the environment. A complex regulatory environmentĬreating the necessary cleanroom infrastructure is easier said than done. Unsurprisingly, the global aseptic processing market is forecast to be worth $24.36 billion by 2031, up from $10.63 billion in 2020. As injection bypasses the body’s defence mechanisms in the gut, these treatments must be produced in a sterile environment to safeguard end patients.Īll of this means that demand for pharmaceutical cleanrooms - a necessary feature of any aseptic processing line - is rising. While the peak of the pandemic has passed, we can still expect demand for COVID-19 boosters to continue for the foreseeable future to protect vulnerable demographics and help overstretched healthcare services.Ī failure to address Annex 1 by August could result in production line closureīiologic formulations are traditionally administered by injection, accounting for this increase in injectable demand. According to IQVIA, global spending on the COVID-19 vaccine totalled $53bn in 2021 and $51bn in 2022. Second, the ongoing mass vaccination programme to bring the COVID-19 pandemic to an end has also been a major contributor to high parenteral demand. The growth of injectables is the result of two developments.įirst, emerging technologies, such as cell and gene therapies, have become the focus of many new players in the development pipeline as a means of treating serious chronic conditions, with global sales of biopharma treatments hitting an all-time high of $300 billion in 2020. As Merrill explains, laminar airflow technology can be a vital tool in meeting these standards. To realise this potential, however, manufacturers must navigate a regulatory environment that places the strictest standards ever devised on eliminating contamination. The increasing demand for injectable drugs is changing the face of the pharmaceutical sector just as new, more complex regulatory schemes are coming into effect.īy 2028, the global market for injectable drugs is set to reach $69.13 billion, with an annual growth rate of 8.9%. ![]()
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